Triton 1.5 Robotic System for Diagnostic Colonoscopy

Initial Clinical Experience With the Triton 1.5 Robotic System for Diagnostic Colonoscopy

This study is a prospective, single-arm, non-randomized, single-site study, focused on evaluating the safety and efficacy of the Triton 1.5 System in diagnostic and basic therapeutic colonoscopy.

This study is a prospective clinical investigation designed to evaluate the safety, and efficacy of the Triton 1.5 System in performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤ 2cm). Up to 40 subjects will undergo robotic colonoscopy using the Triton 1.5 System with three operating physicians.

Inclusion Criteria:

1. Age ≥ 22 years
2. Adults indicated for elective screening, surveillance or diagnostic colonoscopy
3. Subject is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures
4. Subject is willing and able to comply with all protocol required preparation and follow- up visits

Exclusion Criteria:

1. Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
2. Any active or magnetic implantable medical devices (e.g., pacemakers, defibrillators)
3. Previous failed colonoscopy (except for inadequate bowel preparation)
4. BMI > 45 kg/m2
5. Pregnant participants, women of reproductive potential (pre-menopausal and/or no history of hysterectomy), confirmed by a positive pregnancy test (serum).
6. Surgically altered colonic anatomy
7. History of colorectal cancer, inflammatory bowel disease, polyposis syndrome, hereditary nonpolyposis colorectal cancer (Lynch) syndrome, sclerosing encapsulating peritonitis, active diverticulitis in last 6 months or toxic megacolon
8. Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day
9. Known bleeding tendency such as hemophilia or coagulation factor deficiencies
10. Subject receiving antiplatelet or anticoagulation therapy apart from low-dose aspirin
11. Known colonic stricture
12. Known risk factors for abdominal adhesions such as history of complex abdominal or pelvis surgical procedures, based on investigator assessment
13. Known abdominal wall hernias
14. History of radiotherapy to the abdomen or pelvis
15. History of mesenteric ischemia
16. Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy procedure
17. Contraindication to the proposed sedation / anesthesia
18. Received any investigational medicine or treatment within 28 days prior to the colonoscopy procedure
19. Received or planning to receive any other endoscopic procedure within 4 weeks prior and 2 weeks after the colonoscopy procedure
20. Participation in any concurrent clinical trial that may impact the results of this study

Intra-Operative Criteria:

1. Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) (Appendix A) score < 2 in any segment.
2. Any intraoperative finding or condition that, in the Investigator's judgment, would make study participation unsafe or not in the subject's best interest (e.g., significant stricture, tight sigmoid colon precluding safe overtube passage).