Triton 1.5 Robotic System for Diagnostic Colonoscopy in the Middle East

Korábbi kezelés

• Previous failed colonoscopy (except for inadequate bowel preparation)
• Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day
• Subject 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 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 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).

Egyéb

• Any active or magnetic implantable medical devices (e.g., pacemakers, defibrillators)
• BMI > 45 kg/m2
• Pregnant participants
• Surgically altered colonic anatomy
• Known colonic stricture
• Known abdominal wall hernias
• Contraindication to the proposed sedation / anesthesia
• Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) (Appendix A) score < 2 in any segment.

• 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 protocol specific procedures
• Subject is willing and able to comply with all protocol required preparation and follow- up visits