Status:
COMPLETED
Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
Lead Sponsor:
Verily Life Sciences LLC
Conditions:
Colon Adenoma
Colon Polyp
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief Summary
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2022
Estimated Enrollment :
1410 Patients enrolled
Trial Details
Trial ID
NCT05275556
Start Date
March 1 2022
End Date
October 28 2022
Last Update
January 14 2025
Active Locations (7)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Duke Health
Durham, North Carolina, United States, 27710
3
Great Lakes Gastroenterology Research
Mentor, Ohio, United States, 44060
4
Susquehanna Research Group
Camp Hill, Pennsylvania, United States, 17011