The intragastric balloon (IGB) acts as a restrictive procedure with acceptable short-term weight loss outcomes and a low incidence of major complications. This systematic review and meta-analysis aimed to assess whether preoperative insertion of an IGB can reduce perioperative complications and improve weight loss outcomes following metabolic bariatric surgery (MBS). PubMed, Embase, Scopus, and Web of Science databases were searched using relevant keywords to include studies on IGB as a bridge before MBS. The main outcome of this study was to compare the weight loss results and complications after MBS between the IGB group and the control group. For the meta-analysis of variables with severe and non-severe heterogeneity, random-effects and fixed-effects meta-analyses were used, respectively. Eleven articles were included. The IGB and control groups included 318 and 501 patients, respectively. The pooled random-effects analysis of six studies showed that preoperative IGB insertion resulted in a body mass index (BMI) loss of 7.45 kg/m2 over a mean follow-up of 6.14 months. The major complication rate for IGB was 5%. The mean BMI change after MBS between the IGB and control groups was not significantly different after 15.06 months (mean difference - 4.08, p = 0.07). Additionally, a fixed-effects analysis of ten studies found no significant difference in post-MBS complication rates between the IGB and control groups (OR 0.66, p = 0.12). Even though using IGB as a bridging approach to subsequent MBS can result in significant reductions in preoperative BMI, this weight loss does not appear to positively impact the overall outcomes of MBS in patients in the long term.

Background and Objectives: This study aimed to investigate the weight loss, changes in eating habits, and satisfaction with the intragastric balloon (IGB) procedure in patients undergoing treatment for obesity, with follow-up until 6 months after IGB removal. Materials and Methods: This study included patients who underwent the IGB procedure between January 2020 and September 2024 at our clinic and were followed-up for 6 months after IGB removal. Patient records were retrieved from the endoscopy database. Parameters before IGB and during IGB removal were obtained from these records. Upon obtaining verbal consent from patients contacted via their registered phone numbers, their self-reported weights 6 months after IGB removal were recorded, and their body mass index (BMI) was calculated. During the same interview, patients were asked about their eating habits before IGB and 6 months after IGB removal, as well as their satisfaction with the procedure, based on questionnaires used in previous studies. The data collected included patients' age, sex, weight, BMI, percentages of weight and BMI loss at IGB removal and 6 months after IGB removal, duration of IGB placement, maximum weight lost during IGB placement, time to achieve maximum weight lost, changes in eating habits, and satisfaction levels. Results: The mean age of the 62 patients who were included in this study was 33.24 ± 8.71 years, with 37 (59.67%) women and 25 (40.32%) men. The mean weight of the patients before IGB was 91.58 ± 7.04 kg, and the mean BMI was 32.00 ± 4.25 kg/m2. The mean duration of IGB placement was 5.83 ± 0.41 months, with a mean maximum weight loss of 14.22 ± 4.70 kg and a mean time to achieve weight loss of 3.91 ± 0.91 months. There was a statistically significant difference between the weight before the IGB and the weight at IGB removal (p < 0.001). A significant difference was also noted in the weight before the IGB and 6 months after IGB removal (p < 0.001). The comparison of satisfaction levels showed no statistically significant difference in eating habits before the IGB (p = 0.384), whereas a significant difference was found in eating habits 6 months after IGB removal (p < 0.001). The weight loss differences between the satisfied and dissatisfied patients were significant at IGB removal and 6 months after, although no statistical difference was found in the pre-IGB weights between the satisfied and dissatisfied patients (p < 0.001). Conclusions: Patients undergoing the IGB procedure for obesity should correct their poor eating habits to maintain successful mid-term weight loss results.

Management of obesity potentially improves cardiometabolic risk factors in patients with metabolic syndrome (MetS). The Epitomee capsule is a non-pharmacological, biodegradable device treatment for weight reduction in patients with overweight and obesity.

This secondary analysis of the Randomized Evaluation of Safety and Efficacy of the Epitomee capsule Trial (RESET) (a randomized, 24-week, multicenter, placebo-controlled, double-blind trial that enrolled 279 adults aged ≥18 years with a BMI of 27-40 kg/m2) evaluated changes in cardiometabolic parameters in participants treated with Epitomee or placebo combined with lifestyle counseling among (a) the entire RESET study population, and (b) participants meeting diagnostic criteria for prediabetes. Predefined and exploratory endpoints included changes in waist circumference, glycemic parameters, blood pressure, and lipid blood levels; this analysis also assessed percent weight loss in participants with MetS.

Waist circumference, systolic and diastolic blood pressure and some measures of glycemia and lipids, improved with both Epitomee and placebo with no significant differences. Participants with prediabetes treated with Epitomee showed significantly greater reductions in HOMA-IR (p < 0.007) and insulin levels (p < 0.003) than the placebo group. Participants with MetS at baseline experienced significantly greater percent change in initial weight when treated with the Epitomee capsule (n = 27) compared to placebo (n = 31), -8.3% vs -5.2 %, respectively (p < 0.0004). Similar percentages of participants with MetS in both groups achieved ≥5 % weight reduction (59.3 % and 54.8 %, in Epitomee and placebo groups respectively). Significantly more participants with MetS treated with Epitomee achieved ≥10 % weight reduction compared with those treated with placebo (40.7 % vs. 6.5 %, respectively, p < 0.002).

Treatment with either Epitomee and placebo combined with lifestyle improve cardiometabolic risk factors. Compared to placebo, Epitomee significantly reduced HOMA-IR and insulin levels in participants with prediabetes. Among participants with MetS, Epitomee significantly reduced body weight [ClinicalTrials.gov ID NCT04222322].

With increases in obesity and metabolic syndrome because of lifestyle-related factors, the prevalence of non-alcoholic fatty liver disease (NAFLD) also is increasing worldwide. In a subset of patients with NAFLD, an inflammatory process arises in the steatotic liver, known as non-alcoholic steatohepatitis, that leads to liver fibrosis and liver cirrhosis. In selected patients with obesity, bariatric surgery, and bariatric endoscopy are important therapeutic options.

This prospective interventional pilot study was conducted to investigate two types of intragastric balloons (IGB). The IGBs were the Orbera and the Spatz3. Liver fibrosis changes were monitored non-invasively using point and 2D shear wave ultrasound elastography (SWE) and transient elastography that allowed for quantification of liver steatosis using the controlled attenuation parameter (CAP). Patients were followed for 12 months.

Of 34 patients implanted with an IGB, 30 completed follow-up at month 12; results for one patient were excluded because of initiation of obesity pharmacotherapy. Fifteen patients received the Orbera IGB, and nineteen patients received the Spatz3 type. In month 12, total and excess weight loss was 7.88 % and 30.13 %. Elastography values decreased from baseline (3.88 kPa) to 3.61 kPa at month 12 (p 0.024). 2D SWE values decreased from baseline (5.42 kPa) to a value of 4.91 kPa at month twelve (p 0.135). Transient elastography values decreased from baseline (5.62 kPa) to a value of 4.17 kPa at month twelve (p 0.009).

Bariatric endoscopy in the form of IGB implantation leads to weight reduction and improvement of liver fibrosis and steatosis.

NCT04895943.

Both surgical and endoscopic procedures represent a mainstay of obesity treatment. Several procedures have been developed in recent years, although their impact on obesity is variable. This study examines and presents the results of a 6-month gastric balloon implantation (GBI).

The data from the German Bariatric Surgery Registry (GBSR) for the period from 2005 to 2021 were subjected to a multi-center analysis. Six months following GBI, demographic data, the peri-interventional course, weight, BMI reduction, as well as the development of comorbidities (arterial hypertension (aHTN), diabetes mellitus (T2D), reflux (GERD), and sleep apnea syndrome (OSAS)), were evaluated in male and female patients.

Of 3754 patients, 788 (45.3% male, 54.7% female) met the inclusion criteria for the study. Following 6 months of therapy, an average weight loss of 19.3 ± 15.2 kg was observed in male patients, while female patients exhibited an average weight loss of 16.3 ± 13.1 kg (p = 0.013). The EWL was found to be significantly higher in female patients than in male patients (24.8 vs. 18; p < 0.001). BMI reduction, %TWL, and mortality rate showed no significant disadvantage in either group (p > 5%). After 6 months of therapy, there was a significant advantage for women in the remission of aHTN. The remaining comorbidities did not differ significantly between the two groups (p > 5%).

GBI is an efficacious procedure for the treatment of obese patients with mild obesity and comorbidities or as a bridging procedure prior to planned bariatric surgery.

There is noticeable heterogeneity in weight loss outcomes following intragastric balloon (IGB) treatment, with average weight loss ranging between 11% to 15% of total body weight. Genetic variations associated with obesity have been found to influence weight loss response, however such variations are limited. Therefore, the aim of this study is to investigate the impact of the obesity associated brain-derived neurotrophic factor (BDNF) gene polymorphism rs11030104 with weight loss outcomes following IGB treatment.

In this cross-sectional study, BDNF rs11030104 was analysed in 106 individuals who underwent intragastric balloon treatment. Weight loss metrics were evaluated at the three-month follow-up: percentage of total weight loss (%TWL), percentage of excess weight loss (%EWL), and percentage of body mass index loss (%EBMIL). The effects of additive and dominant genetic models were evaluated. Both linear and logistic regression were applied to assess associations between rs11030104 genotypes and weight loss metrics.

A total of 71 participants completed the 3-month follow-up assessment (loss to follow-up: 33%). This study found a significant association between the BDNF rs11030104 polymorphism and weight loss. A-allele carriers showed a better response to IGB treatment. Individuals carrying the AA genotype were found to have a greater %TWL than those carrying the GG genotype at 3 months post-IGB treatment (11.05% vs 5.09%, p=0.003).

Our results suggest that BDNF rs11030104 influences the response to weight loss after IGB treatment and therefore could be added to the growing list of genetic variants that predict greater weight loss response.

Medical devices benefit patients living with overweight or obesity, but studies in the adolescent population are lacking. The goal of this study was to collect information on the performance and safety of a swallowable intragastric balloon program (SGBP) in adolescent patients.

Data were collected retrospectively on patients aged 15 to 17 years with body mass index (BMI) ≥ 27 kg/m2 who received the swallowable intragastric balloon (SGB) and associated lifestyle and nutritional change program. Patients had not responded to previous dietary and behavioral modification weight loss treatments and elected to undergo SGBP. The SGB was swallowed and filled with 550 mL of distilled water in an outpatient setting, and a multidisciplinary team delivered a lifestyle/nutritional change program. Mean % total body weight loss (%TBWL) was calculated for each patient compared with baseline.

A total of 91 patients, 69 (75.8%) female and 22 (24.2%) male, underwent SGBP and completed follow-up through SGB passage at 4 months. Baseline mean ± SD age, weight, and BMI were 16.4 ± 0.77, 99.70 ± 21.33 kg, and 35.60 ± 5.59 kg/m2, respectively. After 4 months, mean weight and BMI were 86.37 ± 18.83 kg and 30.86 ± 5.16 kg/m2 respectively; %TBWL was 13.05 ± 7.64 (1-sided t-test, p < 0.0001). Most (80, 87.9%) reported no adverse events; 11/91 (12.1%) experienced an adverse event. Of these, 9/91 (9.9%) experienced nausea and/or vomiting; 1/91 (1.1%) reported abdominal pain only; 1/91 (1.1%) reported flatulence only. There were no serious adverse events or premature device removals.

The SGBP provides safe and effective short-term weight loss in adolescents living with overweight and obesity.

Obesity is escalating, projected to affect 17.5% of adults globally and afflict 400 million children by 2035. Managing this intricate and chronic condition demands personalized, multidisciplinary approaches. While dietary changes, lifestyle modifications, and medications yield short-term results, long-term outcomes are often poor, with bariatric surgery standing out as the most effective option. However, only a small fraction undergoes surgery due to various barriers. Intragastric balloon (IGB) emerges as a minimally invasive alternative, approved by major regulatory bodies. This review adresses the pivotal role of IGB in obesity management, delving into its history and technological evolution.

Obesity poses a severe health problem worldwide, with an estimated impact on 17.5% of the adult population by 2035. Among the endoscopic applications for treating this comorbidity, intragastric balloons are the most widely used. The new liquid-filled swallowable balloon meets the requirements of major guidelines and allows significant weight loss with few adverse events. This systematic review and meta-analysis aims to demonstrate the efficacy and safety profile of this new device for weight loss.

We conducted a search from 2016 to 2024 to assess the efficacy of the swallowable intragastric balloon for weight loss, including improvements in metabolic profiles and anthropometric measurements. Additionally, we evaluated potential adverse events related to the device to demonstrate its safety.

Eleven observational studies totalling 2107 patients were included, showing a reduction of 4.75 in BMI (95% CI: -5.02; -4.47), a mean total weight loss of 12.47% (95% CI: -13.77; -11.17), a mean excess weight loss of 48.04% (95% CI: -50.61; -45.48), and a rate of serious adverse events of 0.90%. An improvement in the metabolic profile was observed for three parameters: HDL, triglycerides, and glycaemia.

The swallowable liquid-filled intragastric balloon is safe and effective for managing weight loss within a four-month follow-up period.

The intragastric balloon (IGB) is recognised as a minimally invasive intervention for the treatment of obesity. Here, we detail a rare and life-threatening complication stemming from this procedure. A female patient in her 40s, who had an IGB in situ for 14 months, presented at the emergency department with septic shock characterised by abdominal guarding and emesis. These symptoms were a direct result of IGB-induced bowel obstruction. We emphasise that the patient missed the recommended 6-month removal window, which in our opinion is the decisive cause leading to deflated balloon migration and subsequent complications. In the course of managing multiple critical events, the patient required multiple operations related to the bowel obstruction, numerous nutritional and psychological challenges. Currently, the patient is living with short bowel syndrome, secondary to the chronic intestinal failure, necessitating the administration of parenteral nutrition 6 days per week.

Patients with body mass index (BMI) ≥ 50 kg/m2, classified with obesity class IV/V, require complex treatments. Intragastric balloon (IGB) is a possible treatment before metabolic bariatric surgery (MBS) that may reduce peri-operative complications. This study evaluates IGB outcomes and complications before MBS in patients with Obesity IV/V, and subsequent MBS results, regarding weight loss and comorbidity resolution.

Retrospective cohort study of all patients with BMI above 50 kg/m2 submitted to IGB before MBS between 2009 and 2023 in a high-volume center. Variables analyzed included weight loss after IGB and MBS, IGB complications, and comorbidity resolution. Suboptimal clinical responses were defined as %TWL < 5% for IGB, %TWL < 20% for MBS, and %TWL < 25% or BMI ≥ 35 kg/m2 for IGB + MBS.

Seventy-four patients (mean BMI 58.8 ± 8 kg/m2) were included. After IGB, the mean %TWL was 14.2 ± 8.5%, with a 21.6% complication rate, predominantly nausea and vomiting, and one death. Suboptimal clinical response of IGB affected 13.5% of patients, and 5.4% required early removal. Two years after MBS, the mean %TWL was 38.2 ± 11.6%, mainly due to MBS, yet approximately one-third of %TWL was attributed to IGB. No correlation was found between IGB and MBS outcomes. At 2-year follow-up, 45.1% patients had %TWL ≥ 25 and BMI < 35 kg/m2.

The IGB is a treatment option before MBS in patients with Obesity Class IV/V, with acceptable weight loss outcomes but not infrequent complications. A multidisciplinary approach is mandatory, and all treatments must be considered in this difficult subset of patients.

The data on preventive measures for managing obesity prior to surgery is limited. This review highlights the role of stopgap measures for managing obesity before surgery.

Body weight regulation to achieve sustainable weight loss is a gradual process. Regular aerobic exercises, transformative yoga and restrained eating can contribute to a calorie deficit. Behavioural strategies aim to raise awareness, set goals, manage stress, and support adherence to healthier lifestyles. Pharmacotherapy can be adjunctive in inducing weight loss but could be better at maintaining weight. Intragastric balloon and endoscopic sleeve gastroplasty are restrictive procedures for patients before surgery. Obesity is a multifaceted chronic disease with adverse health consequences. There is a need to identify contributors to weight gain and treatment should target the cause of obesity. Utilize stop-gap measures and monitor progress for step-up or more intensive treatment. Structured weight loss needs lifelong commitment.

Intragastric balloon (IGB) is a minimally invasive and reversible option for obesity treatment. There is a worldwide growing number of different IGB models. The efficacy and safety profile for each model must be demonstrated. We aim to evaluate IGB safety profile according to the experience of the Spanish Bariatric Endoscopy Group (GETTEMO).

A survey of 37 IGBs safety-related questions was sent to all GETTEMO members, to retrospectively collect a multicenter Spanish registry. Incidence, causes, and resolution of both major and minor complications and adverse events (AEs), including legal consequences, differentiated for each balloon model were evaluated. Secondary outcome was weight loss data to confirm efficacy.

Twenty-one Spanish hospitals experienced in IGBs responded. The overall data encompassed 20,680 IGBs, including 12 different models. Mean %TBWL of 17.66 ± 2.5% was observed. Early removal rate due to intolerance was 3.62%. Mean major complications rate was 0.70% (> 1% in Spatz2, HB, and Spatz3 models), mainly complicated gastric ulcer. Minor AEs rate was 6.37%, mainly esophagitis. Nine cases (0.04%) required surgery. A single case of mortality (0.0048%) occurred. Seven lawsuits (0.0034%) were received, all with favorable resolution.

In the Spanish experience accumulating 20,680 IGBs and including 12 different balloon models, a low incidence rate of major complications and minor AEs are observed (0.70% and 6.37%, respectively), mostly resolved with medical/endoscopic management. IGB shows good tolerance and efficacy profile. These safety data are within the accepted quality standards.

The treatment of obesity and its comorbidities ranges from clinical management involving lifestyle changes and medications to bariat-ric and metabolic surgery. Various endoscopic bariatric and metabolic therapies recently emerged to address an important therapeutic gap by offering a less invasive alternative to surgery that is more effective than conservative therapies. This article compre-hensively reviews the technical aspects, mechanism of action, outcomes, and future perspectives of one of the most promising endoscopic bariatric and metabolic therapies, named duodenojejunal bypass liner. The duodenojejunal bypass liner mimics the mechanism of Roux-en-Y gastric bypass by preventing food contact with the duodenum and proximal jejunum, thereby initiating a series of hormonal changes that lead to delayed gastric emptying and malabsorptive effects. These physiological changes result in significant weight loss and improved metabolic control, leading to better glycemic levels, preventing dyslipidemia and non-alcoholic fatty liver disease, and mitigating cardiovascular risk. However, concern ex-ists regarding the safety profile of this device due to the reported high rates of severe adverse events, particularly liver abscesses. Ongo-ing technical changes aiming to reduce adverse events are being evaluated in clinical trials and may provide more reliable data to sup-port its routine use in clinical practice.

Metabolic and bariatric surgery (MBS) is widely considered the most effective option for treating obesity, a chronic, relapsing, and progressive disease. Recently, the American Society of Metabolic and Bariatric Surgery (ASMBS) and the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) issued new guidelines on the indications for MBS, which have superseded the previous 1991 National Institutes of Health guidelines. The aim of this study is to establish the first set of consensus guidelines for selecting procedures in Class I and II obesity, using an Expert Modified Delphi Method. In this study, 78 experienced bariatric surgeons from 32 countries participated in a two-round Modified Delphi consensus voting process. The threshold for consensus was set at an agreement or disagreement of ≥ 70.0% among the experts. The experts reached a consensus on 54 statements. The committee of experts reached a consensus that MBS is a cost-effective treatment option for Class II obesity and for patients with Class I obesity who have not achieved significant weight loss through non-surgical methods. MBS was also considered suitable for patients with Type 2 diabetes mellitus (T2DM) and a body mass index (BMI) of 30 kg/m2 or higher. The committee identified intra-gastric balloon (IGB) as a treatment option for patients with class I obesity and endoscopic sleeve gastroplasty (ESG) as an option for patients with class I and II obesity, as well as for patients with T2DM and a BMI of ≥ 30 kg/m2. Sleeve gastrectomy (1) and Roux-en-Y gastric bypass (RYGB) were also recognized as viable treatment options for these patient groups. The committee also agreed that one anastomosis gastric bypass (OAGB) is a suitable option for patients with Class II obesity and T2DM, regardless of the presence or severity of obesity-related medical problems. The recommendations for selecting procedures in Class I and II obesity, developed through an Expert Modified Delphi Consensus, suggest that the use of standard primary bariatric endoscopic (IGB, ESG) and surgical procedures (SG, RYGB, OAGB) are acceptable in these patient groups, as consensus was reached regarding these procedures. However, randomized controlled trials are still needed in Class I and II Obesity to identify the best treatment approach for these patients in the future.

Intra-gastric balloons (IGB) are a mainstay of endoscopic treatment of overweight and obesity. In recent years, an IGB which can remain in situ for 12 months has been developed. The current study aimed to analyse the safety and efficacy of this 12-month IGB.

Consecutive patients receiving the Orbera 365TM IGB (Apollo Endosurgery, TX, USA) between September 2017 and August 2021 were included in a prospective database. Patients received regular follow-up consultations followed by endoscopic removal at 12 months. Demographic data along with weight loss data were collected. All adverse events were recorded.

In total, 1149 patients were included in the study. A majority of the patients were female (87.13%). Median body mass index (BMI) prior to insertion was 36.30 kg/m2 (IQR 32.60-40.00 kg/m2). Median absolute weight loss for all patients was 11.36 kg (IQR 6.70-16.82 kg). There was ongoing sustained weight loss until device removal at week 52. For patients with a weight recording at point of IGB removal, median weight loss was greater (15.88 kg, IQR 10.43-21.72) with percentage total body weight loss of 15.38% (IQR 10.99-21.77) and excess weight loss of 53.99% (IQR 32.44-76.30). Increased patient engagement with post-procedural follow-up was associated with increased weight loss (p<0.001). There were 60 total complications (5.22%). Fifty patients required balloon removal due to intolerance. There were eight cases of balloon rupture. There were only two severe complications (0.17%).

The current study has confirmed safety of this IGB at 12 months with adverse events comparable to published literature. Weight loss increased up until the point of removal at 12 months.

The Epitomee Capsule (EC) is an, oral, self-use, bio-degradable device for weight management, composed of absorbent polymers that self-expands in the stomach (pH-sensitive) and creates a triangular shape, space-occupying super-absorbent gel structure. A recent study reported that 42 % of study completers obtained >5 % weight reduction at 12 weeks. We performed exploratory analyses of this study to evaluate its effect on cardiovascular risk factors and on self-reported satiety, between-meal snacking and meal-size.

This single-center observational study (Israel) enrolled 78 volunteers, with mean age 41 years, BMI 32.5 kg/m2, systolic/diastolic blood pressure (SBP/DBP) 124/77 mmHg. The EC was given in addition to diet and physical activity counseling. Assessments included anthropometrics, BP, lipids, and three questions (translated from Hebrew) scored 1 (not at all) to 5 (very much) for "Do you feel the EC - Q1:helps you to consume less snacks in between meals? Q2:helps you to eat less in the meal?; Q3:is causing an early sense of satiety?". Changes from baseline were assessed using a mixed model and included all patients with at least one measure. Correlation-analysis between weight-change and PROs used Kendall's tau.

Compared to baseline, at 12 weeks, SBP/DBP were reduced (ΔSBP: -5.5 mmHg, p = 0.0003/ΔDBP: -1.9 mmHg, p = 0.1341), with a larger effect in people with hypertension at baseline (ΔSBP: -13.2 mmHg, p < 0.00001/ΔDBP: -6.1, p = 0.008). Triglyceride-level was also significantly reduced, but not other lipids. Mean scores to Q1-3 were high throughout, with slight decreases (Q1 at W2 3.9 ± 1.1/W12 3.0 ± 1.6; Q2 at W2 3.7 ± 1.1/W12 3.1 ± 1.6; Q3 at W2 3.8 ± 1.2/W12 2.9 ± 1.6). There was a moderate correlation between PROs and weight reduction, although significance was not observed for all weeks.

Exploratory analyses of 12 weeks treatment with EC demonstrated significant reductions in SBP, DBP, and triglycerides. The weight reduction correlated with satiety, less snacking, and reduced meal size.

Obesity rates have increased, and so has the need for more specific treatments. This trend has raised interest in non-surgical weight loss techniques that are novel, safe, and straightforward. Thus, the present review describes the endoscopic bariatric treatment for obesity, its most recent supporting data, the questions it raises, and its future directions. Various endoscopic bariatric therapies for weight reduction, such as intragastric balloons (IGBs), aspiration therapy (AT), small bowel endoscopy, endoscopic sleeve gastroplasty, endoluminal procedures, malabsorption endoscopic procedures, and methods of regulating gastric emptying, were explored through literature sourced from different databases. IGBs, AT, and small bowel endoscopy have short-term effects with a possibility of weight regain. Minor adverse events have occurred; however, all procedures reduce weight. Vomiting and nausea are common side effects, although serious complications have also been observed.

The aim of this review is to present the current state of the field, highlight recent developments, and describe the clinical outcomes of these endoluminal bariatric and metabolic procedures.

The landscape of endoluminal devices and techniques for treating obesity has expanded significantly, with FDA-approved therapies currently available to patients with a body mass index values as high as 50 kg/m2. Although notable advancements have been made in this area, there is a need for further emphasis to be placed on the metabolic improvements resulting from these therapies, in addition to the conventional focus on weight loss outcomes. Some of these procedures are now FDA approved for the treatment of metabolic disease as opposed to weight loss. To achieve the most favorable results, it is imperative that all endoluminal interventions are combined with a moderately intensive diet and lifestyle program lasting at least 12 months.

Endoluminal metabolic and bariatric therapy represents a bridge between lifestyle counseling, pharmaceutical interventions, and the most efficacious treatment for obesity, bariatric surgery. By virtue of its minimally invasive approach, this therapy may be an appealing option for patients who are ineligible for, or averse to, bariatric surgery and who have experienced suboptimal outcomes or unable to afford medical treatments. Furthermore, these interventions may be particularly beneficial in the early stages of obesity.

Some patients with overweight or obesity are not eligible for surgery according to international guidelines or do not wish a surgical intervention. For these patients, different treatment options are being explored. In this study, we examined the effectiveness of the swallowable intragastric balloon (IB) combined with lifestyle coaching, in patients living with overweight and obesity.

A retrospective data study was conducted on patients with a swallowable IB placement between December 2018 and July 2021, combined with a 12-month coaching program. Before balloon placement, patients underwent multidisciplinary screening. The IB was swallowed and filled with fluid once in the stomach and naturally excreted around 16 weeks.

A total of 336 patients, 71.7% female, were included with a mean age of 45.7 (±11.7) years. Mean baseline weight and BMI were 107.54 (±19.16) kg and 36.1 (±5.02) kg/m². After 1 year, the mean total weight loss was 11.0% (±8.4). The mean placement duration was 13.1 (±2.82) min, and in 43.7%, a stylet was used to facilitate placement. The most common symptoms were nausea (80.4%) and gastric pain (80.3%). In the majority of patients, complaints were resolved within a week. The early deflation of the balloon occurred in 8 patients (2.4%) of which one showed symptoms suggesting a gastric outlet obstruction.

Given the low rate of long-term complaints while providing a positive effect on weight loss, we conclude that the swallowable intragastric balloon, combined with lifestyle coaching, is a safe and effective treatment option for patients living with overweight and obesity.

Obesity is a worldwide epidemic and is the second leading cause of preventable death. The approach to treating obesity involves a multidisciplinary approach including lifestyle interventions, pharmacological therapies, and bariatric surgery. Endoscopic interventions are emerging as important tools in the treatment of obesity with primary and revisional bariatric endoscopic therapies. These include intragastric balloons, aspiration therapy, suturing and plication, duodenal-jejunal bypass liners, endoscopic duodenal mucosal resurfacing, and incisionless magnetic anastomosis systems. Endoscopic interventions have also demonstrated efficacy in treating complications of bariatric surgery. Approaches include stenting, endoscopic internal drainage, and endoscopic vacuum-assisted closure. This review aimed to discuss the current endoscopic procedures used as primary and revisional bariatric therapy including those used for managing bariatric surgical complications.

It is estimated that by 2030, 38% of the world population will be overweight, and another 20% will be people with obesity. Intragastric balloons (IGBs) are an option in conjunction with lifestyle modification for the treatment of obesity. We sought to investigate the effects of IGB therapy on hemoglobin A1c (A1c), systolic and diastolic blood pressure (SBP, DBP), total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides (TGs).

PubMed, Embase, and Google Scholar were queried through November 2021 to identify studies that evaluated the effects of IGB therapy on selected variables at 6 months. A total of 17 studies and 1198 patients met inclusion criteria. Results were pooled using a random-effects model.

At 6-month post-IGB insertion, patients had a significant reduction in A1c (mean difference (MD): - 0.62, 95% confidence interval (CI): - 0.884 to - 0.355, p < 0.001), SBP (MD: - 8.39, 95% CI: - 11.39 to - 5.386, p < 0.001), DBP (MD: - 5.807, 95% CI: - 8.852 to - 2.76, p < 0.001), TC (MD: - 9.189, 95% CI: - 15.763 to - 2.616, p = 0.006), LDL (MD: - 5.20, 95% CI: - 9.05 to - 1.35, p = 0.008), and TGs (MD: - 25.35, 95% CI: - 40.30 to - 10.10, p = 0.001). There was no significant difference in HDL (MD: 1.245, 95% CI: - 0.11 to 2.60, p = 0.071).

Our meta-analysis suggests that IGB therapy is associated with improvements in insulin resistance, blood pressure, and dyslipidemia at 6 months. The results of this analysis suggest that IGB placement can be a viable treatment option to improve important metabolic parameters beyond weight loss alone.

The rising prevalence of obesity, and related morbidity and mortality, has necessitated the development of therapeutic weight loss strategies. Lifestyle modifications alone have only yielded modest benefit, and while bariatric surgery has shown significant short- and long-term results, only a minority of eligible patients end up receiving this treatment. Endoscopic bariatric and metabolic therapies (EBMTs) are a rapidly evolving field, which provides a less invasive middle ground treatment option for weight loss. Here we discuss the efficacy, as well as short- and long-term outcomes with restrictive, malabsorptive/metabolic and aspiration endoscopic techniques, and their effects on metabolic parameters.

intragastric balloons (IGBs) are a minimally invasive, increasingly popular option for obesity treatment. However, there is only one worldwide guideline standardizing the technical aspects of the procedure (BIBC, SOARD 2018).

to construct a practical guideline for IGB usage by reproducing and expanding the BIBC survey among the Spanish Bariatric Endoscopy Group (GETTEMO).

a 140-question survey was submitted to all GETTEMO members. Twenty-one Spanish experienced endoscopists in IGBs answered back. Eight topics on patient selection, indications/contraindications, technique, multidisciplinary follow-up, results, safety, and financial/legal aspects were discussed. Consensus was defined as consensus ≥ 70 %.

overall data included 20 680 IGBs including 12 different models. Mean age was 42.0 years-old, 79.9 % were women, and the mean preoperative body mass index (BMI) was 34.05 kg/m². Indication in BMI > 25 kg/m², 10 absolute contraindications, and nutritional and medication measures at follow-up were settled. A mean %TBWL (total body weight loss) of 17.66 % ± 2.5 % was observed. Early removal rate due to intolerance was 3.62 %. Adverse event rate was 0.70 % and 6.37 % for major and minor complications with consensual management. A single case of mortality occurred. IGBs were placed in private health, prior contract, and with full and single payment at the beginning. Seven lawsuits (0.034 %) were received, all ran through civil proceeding, and with favorable final resolution.

this consensus based on more than 20 000 cases represents practical recommendations to perform IGB procedures. This experience shows that the device leads to satisfactory weight loss with a low rate of adverse events. Most results are reproducible compared to those obtained by the BIBC.

Background Obesity is the most well-established and prolonged pandemic in modern society. Having a better understanding of the available tools is important to improve weight loss and make the strategies more productive. This study aims to evaluate the effect of intragastric balloon (IGB) on gastric emptying time, its relationship with weight loss after IGB removal, and weight maintenance after six years. Methodology This prospective study analyzed data from patients undergoing IGB placement. A six-years follow-up was performed and data about weight maintenance were collected. We analyzed the impact of the IGB on gastrointestinal motility and its correlation with weight loss. Results Of the 20 patients included in the study, 52.4% were diagnosed with class I obesity and 47.6% with class II obesity. The mean weight of the patients was 96.5 ± 11.9 kg at baseline, 79.6 ± 11.4 kg at the time of IGB removal, 81.8 ± 9.1 kg at six months, and 93.2 ± 14.3 kg six years after IGB removal. The mean difference between the initial weight and that measured immediately after IGB removal was 16.68 ± 5.71 kg. Regarding gastric emptying time, there was a difference in retention on comparing the measurement before balloon placement to that after the balloon was in place (72.9% vs. 86.8%) after one hour of food intake. Comparing two hours after food intake, patients before IGB placement had a 30.6% food retention, while patients with IGB in place had a 69.2% retention. Conclusions In patients with class I or II obesity, the use of an IGB delayed gastric emptying of foods but showed no direct correlation with weight loss. Weight loss achieved after IGB placement was maintained in half of the patients at a six-year follow-up.

Approximately 20% of children and adolescents in the USA suffer from obesity with significant long-term effects well into adulthood. Metabolic and bariatric surgery, although well adopted in the adult population, has been underutilized in children.

There are four categories of weight loss devices regulated by the Food and Drug Administration for use in adults - gastric bands, gastric balloon systems, electrical stimulation systems, and gastric emptying systems. In this commentary we discuss the role these devices may play in increasing the adoption of procedural intervention for severe obesity in children and adolescents.

Background and study aims  There is minimal research on real-world, large-volume data comparing endoscopic bariatric therapy (EBT) to laparoscopic bariatric therapy (LBT). This study aimed to compare 30-day postoperative morbidity and mortality outcomes of primary EBT vs LBT using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Patients and methods  Patients aged 18 to 80 with body mass index (BMI) 35 to 40 kg/m ² undergoing primary procedures were included. Propensity score matching 1:50 was performed for EBT versus LBT based on age, sex, and BMI. Results  We matched 211 EBTs with 9,059 LBTs. Operative length (63.9, 95 % confidence interval [CI]: 57.9, 69.8 versus 81.1, 95 % CI: 80.1, 82.1) and length of stay (0.49 days, 95 % CI: 0.29, 0.69 versus 1.43 days, 95 % CI: 1.41, 1.45) were significantly lower in the EBT group than the LBT group. There was no difference between EBT and LBT in the odds of readmission (odds ratio [OR] = 0.31, 95 % CI: 0.08, 1.25), reoperation (OR = 0.39, 95 % CI: 0.05, 2.84), or reintervention (OR = 0.98, 95 % CI: 0.24, 3.99). After controlling for chronic obstructive pulmonary disease, sleep apnea, history of myocardial infarction, hypertension requiring medications, and diabetes, EBT continued to be associated with lower odds of having any adverse event (AE) than LBT, with an OR of 0.34 (95 % CI: 0.16, 0.69). Subgroup analysis comparing EBT to laparoscopic sleeve gastrectomy (LSG) showed that EBT was associated with a lower risk having any AE than LSG, with an OR of 0.39 (95 % CI: 0.19, 0.79). Conclusions  EBT is associated with a lower 30-day AE rate and shorter procedural length and length of stay than LBT, with similar rates of readmission, reintervention, and reoperation.

Obesity with type-2 diabetes is a global challenge. Lifestyle interventions have limited effect for most patients. Bariatric surgery is highly effective, but resource-demanding, invasive and associated with serious complications. Recently, a new intragastric balloon was introduced, not requiring endoscopy for placement or removal (Elipse™, Allurion Inc., Natick, MA). The balloon is swallowed in a capsule and filled with water once in the stomach. The balloon self-deflates after 4 months and is naturally excreted. The present trial investigated balloon feasibility, safety and efficacy in patients with obesity and type-2 diabetes.

We treated 19 patients, with type-2 diabetes and body mass index (BMI) of 30.0-39.9 kg/m² at two Norwegian centers with the Elipse balloon. Patient follow-up during balloon treatment mimicked real-world clinical practice, including dietary plan and outpatient visits. The primary efficacy endpoints were total body weight loss (TBWL) and HbA1c at weeks 16 and 52.

All patients underwent balloon insertion uneventfully as out-patients. Mean TBWL and HbA1c reduction after 16 and 52 weeks of balloon insertion was 3.9% (95%CI 2.1-5.7) and 0.8% (95%CI 1.9-3.5); and 7 (95%CI 4-10), and 1 (95%CI -6 to 9) mmol/mol, respectively. Adverse events occurred in two patients (10.5%): one developed gastric outlet obstruction, managed by endoscopic balloon removal; the other excessive vomiting and dehydration, managed conservatively.

This first Scandinavian real-world clinical trial with a new minimally invasive intragastric balloon system demonstrated good feasibility, but did not confirm expected efficacy for weight loss and diabetes control.

Primary obesity surgery endoluminal (POSE) utilizes an incision-less operating platform system to create full-thickness plications in the gastric fundus and body (original POSE). Many studies have demonstrated the safety and efficacy of original POSE for the treatment of obesity.

We aimed to conduct a systematic review and meta-analysis of available literature in an attempt to evaluate the outcomes of original POSE per the ASGE task force thresholds.

Bibliographic databases were systematically searched for studies assessing the outcomes of POSE for the treatment of obesity. All randomized controlled trials (RCTs) and observational studies that assessed outcomes of POSE were included. Studies were included if they reported percent total weight loss (%TWL) or percent excess weight loss (%EWL) and the incidence of serious adverse events (SAE).

A total of seven studies with 613 patients were included. Two included studies were RCTs, while the remaining were observational studies. Pooled mean %EWL at 3-6 months and 12-15 months were 42.62 (95% CI 37.56-47.68) and 48.86 (95% CI 42.31-55.41), respectively. Pooled mean %TWL at 3-6 months and 12-15 months was 13.45 (95% CI 8.93-17.97) and 12.68 (95% CI 8.13-17.23), respectively. Subgroup analysis of two RCTs showed that weight loss at 1 year was significantly higher in POSE patients (%EWL difference in means 19.45 (95% CI 4.65-34.24, p value = 0.01). The overall incidence of serious adverse events was only 2.84% and included GI bleeding, extra-gastric bleeding, hepatic abscess, severe pain, severe nausea, and severe vomiting. The mean number of total anchors placed in the fundus and body was 13.18 (95% CI 11.77-14.58), and the mean procedure time was 44.55 min (95% CI 36.44-52.65).

POSE, a minimally invasive endoscopic bariatric therapy, is a safe and effective modality for the treatment of obesity. The outcomes of POSE meet and surpass the ASGE joint task force thresholds. Future studies should evaluate newer versions of this procedure that emphasize gastric body plication sparing the fundus.

Bariatric surgery for patients with severe obesity (body mass index (BMI) ≥ 50kg/m²) is technically challenging. Intragastric balloon (IGB) has been proposed for weight loss before bariatric surgery to reduce surgical risks but its efficacy remains unclear. We conducted a systematic review and meta-analysis of the effectiveness of IGB as bridging therapy and assess potential complications. Amongst 2419 citations, 13 studies were included. IGB resulted in a BMI reduction of 6.60 kg/m² (MD=6.60, 95% CI: 5.06-8.15; I²=72%). The total post-procedural complication rate was 8.13% (95% CI: 4.04-13.17%), with majority being balloon intolerance. Overall, IGB is effective as a bridging therapy with adequate procedural safety profile, but further study is needed to evaluate the risk reduction for bariatric surgery and long-term weight-loss outcomes.

Metabolic dysfunction-associated fatty liver disease corresponds to a clinical entity that affects liver function triggered by the accumulation of fat in the liver and is linked with metabolic dysregulation.

To evaluate the effects of the intragastric balloon (IGB) in patients with metabolic dysfunction-associated fatty liver disease through the assessment of liver enzymes, imaging and several metabolic markers.

A comprehensive search was done of multiple electronic databases (MEDLINE, EMBASE, LILACS, Cochrane and Google Scholar) and grey literature from their inception until February 2021. Inclusion criteria involved patients with a body mass index > 25 kg/m2 with evidence or previous diagnosis of hepatic steatosis. Outcomes analyzed before and after 6 mo of IGB removal were alanine aminotransferase (IU/L), gamma-glutamyltransferase (IU/L), glycated hemoglobin (%), triglycerides (mg/dL), systolic blood pressure (mmHg), homeostatic model assessment, abdominal circumference (cm), body mass index (kg/m2) and liver volume (cm3).

Ten retrospective cohort studies evaluating a total of 508 patients were included. After 6 mo of IGB placement, this significantly reduced alanine aminotransferase [mean difference (MD): 10.2, 95% confidence interval (CI): 8.12-12.3], gamma-glutamyltransferase (MD: 9.41, 95%CI: 6.94-11.88), glycated hemoglobin (MD: 0.17%, 95%CI: 0.03-0.31), triglycerides (MD: 38.58, 95%CI: 26.65-50.51), systolic pressure (MD: 7.27, 95%CI: 4.79-9.76), homeostatic model assessment (MD: 2.23%, 95%CI: 1.41-3.04), abdominal circumference (MD: 12.12, 95%CI: 9.82-14.41) and body mass index (MD: 5.07, 95%CI: 4.21-5.94).

IGB placement showed significant efficacy in improving alanine aminotransferase and gamma-glutamyltransferase levels in patients with metabolic dysfunction-associated fatty liver disease as well as improving metabolic markers related to disease progression.

Intragastric balloon (IGB) is a minimally invasive and reversible therapy for weight loss with a good efficacy and safety profile. Introduced in the 1980s, IGBs have significantly evolved in the last couple of decades. They mechanically act by decreasing the volume of the stomach and its reservoir capacity, delaying gastric emptying, and increasing satiety leading to a subsequent weight loss. Despite the low rates of complications and mortality associated with IGBs, adverse events and complications still occur and can range from mild to fatal. This review aims to provide an update on the current scientific evidence in regard to complications and adverse effects of the use of the IGB and its treatment. This is the first comprehensive narrative review in the literature dedicated to this subject.

Duodenal mucosal resurfacing (DMR) is an innovative endoscopic bariatric and metabolic therapy (EBMT) emerging in recent years. It uses the duodenum to achieve better glycemic and weight control. This study aimed to evaluate in a critical and systematic way the metabolic effects of this procedure. Electronic searches were performed evaluating the DMR procedure based on predefined inclusion and exclusion criteria. Changes in measured outcomes were evaluated using random-effects models by computing weighted mean differences (MD) and corresponding 95% CIs between pre-and post-procedure metabolic characteristics. Four studies were selected for qualitative and quantitative analysis. DMR demonstrated beneficial glycemic and hepatic metabolic effects among patients with non-insulin dependent type 2 diabetes (T2D) at 3 and 6 months post-procedure.

Obesity is becoming increasingly prevalent worldwide, and its metabolic sequelae lead to a significant burden on healthcare resources. Options for the management of obesity include lifestyle modification, pharmacological treatment, surgery, and endoscopic bariatric therapies (EBTs). Among these, EBTs are more effective than diet and lifestyle modification and are less invasive than bariatric surgery. In recent years, there have been significant advances in technologies pertaining to EBTs. Of all the available EBTs, there is a significant amount of clinical experience and published data regarding intragastric balloons (IGBs) because of their comparatively long development period. Currently, the United States Food and Drug Administration (FDA) has approved three IGBs, including Orbera (Apollo Endosurgery, Austin, TX, USA), ReShape Duo (ReShape Medical, San Clemente, CA, USA), and Obalon (Obalon Therapeutics, Carlsbad, CA, USA). The aim of this review is to summarize the available literature on the efficacy of IGBs in weight loss and their impact on obesity-related metabolic diseases.

We aimed to individually evaluate IGB and ESG procedures and compare the efficacy, durability, and safety of these procedures.

Bibliographic databases were systematically searched for studies investigating the use of IGB and ESG for the treatment of obesity. Studies reporting percent total weight loss (%TWL) or percent excess weight loss (%EWL) with at least 12 months of follow-up were included.

A total of 28 studies were included in the final analysis. Only 1 study directly compared ESG to IGB, 9 studies evaluated ESG alone, while 18 studies evaluated IGB. At 12-month follow-up after ESG, mean %TWL was 17.51 (95% CI 16.44-18.58), and %EWL was 60.51 (95% CI 54.39-66.64). Mean %TWL and %EWL after IGB at 12 months was 10.35 (95% CI 8.38-12.32) and 29.65 (95% CI 25.40-33.91), respectively. Mean %TWL and %EWL after IGB were significantly decreased at 18 or 24 months compared to 6 months indicating weight regain after IGB removal. ESG achieved significantly superior weight loss compared to IGB, the difference in mean %TWL was 7.33 (95% CI 5.22-9.44, p value = 0.0001) at 12 months. Serious adverse events were observed in < 5% for both procedures.

Although ESG and IGB are safe and effective for weight loss, our study suggests that ESG results in more significant and sustained weight loss. Nevertheless, a variety of approaches are essential to care for this underserved population, and there are several factors other than weight loss that should be considered in selecting the ideal therapy for individual patients.