Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagnosis of Lower Gastrointestinal Conditions

Launched by NEPTUNE MEDICAL · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new technology called the Triton 4.0 System, which uses robotics to perform colonoscopies. Colonoscopies are important procedures used to screen for colorectal cancer and other conditions in the lower gastrointestinal tract. The trial will take place in two phases: the first phase will assess the safety of using this robotic system, and the second phase will evaluate how well it works in practice. The study is not yet recruiting participants, but when it does, it will involve adults aged 22 and older who need a colonoscopy for screening, surveillance, or diagnosis.

To participate, individuals must be willing to provide informed consent and follow the necessary preparation and follow-up steps. However, certain people may not be eligible, such as those with specific medical conditions, previous failed colonoscopies, or those who have had certain surgeries. Participants can expect to be closely monitored for safety during the procedure and will help contribute to understanding how this new robotic system can improve colonoscopy procedures for patients in the future.

Gender

ALL

Eligibility criteria

• • 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 Clinical Investigation Plan specific procedures
• • 4. Subject is willing and able to comply with all Clinical Investigation Plan required preparation and follow- up visits -
• Exclusion Criteria:
• Initial Screening / Pre-Operative:
• • 1. Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
• • 2. Any active 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. Patient 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 Exclusion Criteria:
• • 21. Inadequate Bowel Preparation, Boston Bowel Prep Scale Score (after cleansing) \< 2 in any section
• • 22. Failed conventional colonoscopy or polypectomy/biopsy performed during the conventional colonoscopy procedure in Phase A
• • 23. Any presenting condition discovered intraoperatively that in the opinion of the investigator would make participating in this study not in the participant's/patient's best interest. For example, presence of a stricture or tight sigmoid that would make passing an overtube risky for the patient
• • 24. Any condition, in the opinion of the Investigator, that is unstable and could jeopardize the safety of the subject and their compliance in the study