Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Verily Life Sciences LLC
- Enrollment
- 1,410
- Locations
- 12
- Primary Endpoint
- Difference in Adenomas Per Colonoscopy (APC)
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Outcomes Assessor)
Masking Description
Subjects, investigators, study site personnel, and pathologists will not be blinded to treatment assignments. All Verily personnel involved in the statistical analysis of this study will be blinded to treatment assignment. For the interim analysis, unblinded analysis will be performed by an independent statistician, the results of which will be communicated to a select group of Verily personnel not involved in the study management.
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Difference in Adenomas Per Colonoscopy (APC)
Time Frame: Day 1
Difference in Adenomas Per Colonoscopy (APC) between the control and intervention arm, evaluated for superiority. APC is defined as the average number of histologically confirmed adenomas resected per colonoscopy.
Difference in Positive Percent Agreement (PPA)
Time Frame: Day 1
Difference in Positive Percent Agreement (PPA) between the control and intervention arm, evaluated for non-inferiority. PPA is defined as the total number of histologically confirmed Clinically Significant Excised Lesions, divided by the total number of excisions.
Secondary Outcomes
- Adenoma Detection Rate (ADR)(Day 1)
- Number of False Alerts Per Procedure(Day 1)
- Mean Withdrawal and Inspection Time (MWT)(Day 1)
- Polyp Detection Rate (PDR)(Day 1)
- Proximal Adenoma Detection Rate (pADR)(Day 1)
- Flat Adenoma Detection Rate (fADR)(Day 1)
- Serrated Lesions Per Colonoscopy (SLPC)(Day 1)
- Serrated Lesions Detection Rate (SLDR)(Day 1)
- Adenoma Detection Rate Including Carcinoma (ADR*)(Day 1)
- Small Adenoma Detection Rate (sADR)(Day 1)
- Polyps Per Colonoscopy (PPC)(Day 1)
- Advanced Adenoma Detection Rate (aADR)(Day 1)
- False Positive Rate (FPR)(Day 1)