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.
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 -
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