Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagno… (NCT06935734) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Robotic Colonoscopy Using the Triton 4.0 System in Adults for Screening, Surveillance, and Diagnosis of Lower Gastrointestinal Conditions
50 participantsStarted 2025-04-14
Plain-language summary
This study is a prospective, single-arm, non-randomized, single site first-in-human study and will be conducted in two phases, where Phase A will serve to evaluate the safety of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies, and Phase B will evaluate the safety and efficacy of the Triton 4.0 System to perform screening, surveillance and diagnostic colonoscopies.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. Age ≥ 22 years
✓. Adults indicated for elective screening, surveillance or diagnostic colonoscopy
✓. Subject is willing and able to provide written informed consent prior to receiving any non-standard of care Clinical Investigation Plan specific procedures
✓. Subject is willing and able to comply with all Clinical Investigation Plan required preparation and follow- up visits -
Exclusion criteria
✕. Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
✕. Any active implantable medical devices (e.g., pacemakers, defibrillators)
✕. Previous failed colonoscopy (except for inadequate bowel preparation)
✕. BMI \> 45 kg/m2
✕. Pregnant participants, women of reproductive potential (pre-menopausal and/or no history of hysterectomy), confirmed by a positive pregnancy test (serum).
✕. Surgically altered colonic anatomy
✕. 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
✕
What they're measuring
1
Safety Endpoint - Incidence of Major Adverse Events Within 48 Hours
Timeframe: 48 hours
2
Efficacy Endpoint - Successful Completion of Colonoscopy