Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)

Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)

This is a prospective, multicenter, randomized controlled study to evaluate the effect of the Computer-Assisted Detection (CADe) Device on Adenomas Per Colonoscopy and Positive Percent Agreement for routine colonoscopies. The control arm is colonoscopy performed with High Definition White Light Endoscopy (HD-WLE) per standard of care. The intervention arm is colonoscopy performed with HD-WLE per standard of care plus the Computer-Assisted Detection (CADe) Device.

Inclusion Criteria:

• Scheduled to undergo routine screening (including, but not limited to, FIT/Cologuard positive), routine surveillance (≥3 years as scheduled since last colonoscopy), or diagnostic (symptomatic) colonoscopy with High Definition White Light Endoscopy.
• Between the ages of 45 and 80 years, inclusive
• Able and willing to provide written informed consent

Exclusion Criteria:

• Self-reported pregnancy
• Known diagnosis of Colorectal Cancer
• History of, or referral for, Inflammatory Bowel Disease
• Previous surgery involving the colon or rectum
• Referral for known polyp or assessment of post-polypectomy site (i.e. less than 3 years since last colonoscopy).
• High suspicion or diagnosis of genetic polyposis syndromes, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), or any other high-risk family history meeting Bethesda guidelines.
• Referral for overt, symptomatic gastrointestinal bleeding