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

Completed · Not applicable

Conditions studied: Colon Adenoma, Colon Polyp, Colon Lesion

In brief

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.

Key facts

Study ID

NCT05275556

Run by

Verily Life Sciences LLC

People needed

1410

Starts

2022-03-01

Expected to finish

2022-10-28

Last updated by the study team

2025-01-14

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Duke Health — Durham, North Carolina, United States
• Great Lakes Gastroenterology Research — Mentor, Ohio, United States
• Susquehanna Research Group — Camp Hill, Pennsylvania, United States
• ANRC Research — El Paso, Texas, United States
• Elisha Medical Center — Haifa, Israel
• Sourasky Medical Center (Ichilov) — Tel Aviv, Israel

Full record on ClinicalTrials.gov

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