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

Verily Life Sciences

Status

Completed

Conditions

Colon Lesion

Colon Adenoma

Colon Polyp

Treatments

Device: Computer-Assisted Detection (CADe) Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT05275556

103820

Details and patient eligibility

About

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.

Enrollment

1,410 patients

Sex

All

Ages

45 to 80 years old

Volunteers

Accepts Healthy Volunteers

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