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

Korábbi kezelés

• Previous failed colonoscopy (except for inadequate bowel preparation)
• Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day
• Patient receiving antiplatelet or anticoagulation therapy apart from low-dose aspirin
• Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy procedure
• Received any investigational medicine or treatment within 28 days prior to the colonoscopy procedure
• Received or planning to receive any other endoscopic procedure within 4 weeks prior and 2 weeks after the colonoscopy procedure
• Participation in any concurrent clinical trial that may impact the results of this study
  • Intra-Operative Exclusion Criteria:

Más betegség

• Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
• 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
• Known bleeding tendency such as hemophilia or coagulation factor deficiencies
• Known risk factors for abdominal adhesions such as history of complex abdominal or pelvis surgical procedures, based on investigator assessment
• History of radiotherapy to the abdomen or pelvis
• History of mesenteric ischemia
• 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
• 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

Laborértékek

• Pregnant participants, women of reproductive potential (pre-menopausal and/or no history of hysterectomy), confirmed by a positive pregnancy test (serum).

Egyéb

• Initial Screening / Pre-Operative:
• Any active implantable medical devices (e.g., pacemakers, defibrillators)
• BMI > 45 kg/m2
• Surgically altered colonic anatomy
• Known colonic stricture
• Known abdominal wall hernias
• Contraindication to the proposed sedation / anesthesia
• Inadequate Bowel Preparation, Boston Bowel Prep Scale Score (after cleansing) < 2 in any section
• Failed conventional colonoscopy or polypectomy/biopsy performed during the conventional colonoscopy procedure in Phase A

• 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 -