Winters C, Subramanian V, Valdastri P. Robotic, self-propelled, self-steerable, and disposable colonoscopes: Reality or pipe dream? A state of the art review. World J Gastroenterol 2022; 28(35): 5093-5110 [PMID: 36188716 DOI: 10.3748/wjg.v28.i35.5093]
Corresponding Author of This Article
Conchubhair Winters, MBChB, Doctor, Research Fellow, Leeds Institute of Medical Research, University of Leeds, St. James’s University Hospital, Beckett Street, Leeds LS9 7TF, United Kingdom. c.r.winters@leeds.ac.uk
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Review
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Gastroenterol. Sep 21, 2022; 28(35): 5093-5110 Published online Sep 21, 2022. doi: 10.3748/wjg.v28.i35.5093
Table 1 The features of the ideal robotic colonoscope
No.
Ideal robotic colonoscope features
1
Affordable
2
Acceptable to patients and endoscopists
3
More comfortable than conventional colonoscopy
4
Lower risk than conventional colonoscopy
5
Improved caecal intubation rate compared to conventional colonoscopy
6
Offer at least comparable mucosal visibility with the option of image enhancement (virtual chromoendoscopy)
7
Capable of taking biopsies and therapeutics such as polypectomy
8
Offer integration with artificial intelligence for polyp detection and characterisation
9
Ideally have autonomous features, such as self-navigation
10
Reduce the training time to achieve competence compared to conventional colonoscopy
11
Procedure times should be less than, but must not be significantly longer than, conventional colonoscopy
12
Have sustainability in mind in the manufacturing, reprocessing or disposal of the device
Table 2 Advantages and limitations of conventional colonoscopy alternatives
Procedure
Advantages
Limitations
Conventional colonoscopy
Extensive knowledge base and expertise already available, diagnostic and therapeutic capabilities. Gold standard
Bowel cleansing required, painful for some (sedative and analgesics often required), prolonged training period required, risk of perforation due to forces required
Lower intensity bowel cleansing, shorter procedure, less discomfort (no sedation or analgesia needed), other intraabdominal pathology can be detected, lower risk of perforation, better patient tolerance
Low dose radiation used, lower sensitivity for small and flat polyps, no therapeutic capability, no direct mucosal visualisation, limited evidence of a benefit in CRC incidence or mortality
Aggressive bowel cleansing required, lower sensitivity than CC for polyps, no control of the capsule, no therapeutic capability, risk of capsule retention, limited battery life can cut out before complete colon visualisation
Table 3 Technology readiness levels as applicable to robotic colonoscopy[57,102,103]
TRL
Definition
Supporting information relevant to robotic colonoscopy
1
Basic principles observed and reported
Published research on the core principals of the technology
2
Technology concept and/or application formulated
Moving from principals to applied research with potential applications speculated
3
Analytical and experimental proof of concept
Active research and development proving the concept within a laboratory setting. Benchtop testing
4
Component validation in laboratory environment
Proof of concept and safety in an ex-vivo animal colon
5
Component/system validation in a relevant environment
In-vivo animal testing with an aim at providing relevant evidence for human testing or FDA approval
6
High fidelity alpha protype demonstration in a relevant environment
Clinical trials assessing feasibility and safety in small number of humans
7
Beta prototype demonstrated in a relevant environment
Clinical safety and effectiveness trials. Determination of risks and adverse events. Final design validation
8
Completed system and qualified to relevant requirement/standards through testing and demonstration
FDA or equivalent approval
9
Actual system proven through successful operation
Device being marked with post-market studies proving real world operational capability
Table 4 Active flexible colonoscopy platforms with technology readiness level
2020: Learning curve study of 57 participants. CIR and CIT improved to 100% and 22 min following a learning block. PREMs: Mild or no discomfort in most
CE marked and FDA approved. Commercially available in Europe and Japan
8
Invendoscope-Invendo Medical GmbH, Weinheim, Germany (acquired by Ambu A/S, Copenhagen, Denmark in 2017)[21,77-79]
2018: Human study on 40 participants using the SC210 model. CIR 95%. CIT 14.2 min. No PREMs on this study, but previous studies reported lower pain scores than CC
CE marked and FDA approved. No longer manufactured
8
Magnetic Flexible Endoscope-STORM lab, Leeds, United Kingdom & Nashville, TN, United States[4,53,85,86,104]
2020: In-vivo porcine study. Clinical trial due 2022
No regulatory approvals
5
Citation: Winters C, Subramanian V, Valdastri P. Robotic, self-propelled, self-steerable, and disposable colonoscopes: Reality or pipe dream? A state of the art review. World J Gastroenterol 2022; 28(35): 5093-5110