N/A
N=1,410
Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
Colon Adenoma · Colon Polyp · Colon Lesion
Bottom Line
View on ClinicalTrials.gov: NCT05275556 ↗Enrolled (actual)
1,410
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Difference in Adenomas Per Colonoscopy (APC) — 0.60; 0.74 Resected adenomas — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Computer-Assisted Detection (CADe) Device (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Verily Life Sciences LLC
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Adenomas Per Colonoscopy (APC) |
0.60; 0.74 | 0.0002 sig |
| PRIMARY Difference in Positive Percent Agreement (PPA) |
0.62; 0.56 | 0.09 |
| SECONDARY Adenoma Detection Rate (ADR) |
38.9; 42.9 | 0.031 sig |
| SECONDARY Number of False Alerts Per Procedure |
417 | — |
| SECONDARY Mean Withdrawal and Inspection Time (MWT) |
8.97; 9.34 | 0.169 |
| SECONDARY Polyp Detection Rate (PDR) |
364; 425 | — |
| SECONDARY Proximal Adenoma Detection Rate (pADR) |
198; 236 | 0.0578 |
| SECONDARY Flat Adenoma Detection Rate (fADR) |
19; 21 | 0.7813 |
| SECONDARY Serrated Lesions Per Colonoscopy (SLPC) |
0.34; 0.46 | — |
| SECONDARY Serrated Lesions Detection Rate (SLDR) |
156; 219 | 0.0004 sig |
| SECONDARY Adenoma Detection Rate Including Carcinoma (ADR*) |
271; 307 | 0.1185 |
| SECONDARY Small Adenoma Detection Rate (sADR) |
201; 236 | 0.0752 |
| SECONDARY Polyps Per Colonoscopy (PPC) |
1.03; 1.32 | — |
| SECONDARY Advanced Adenoma Detection Rate (aADR) |
60; 59 | 0.8194 |
| SECONDARY False Positive Rate (FPR) |
0.22; 0.31 | 0.0008 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05275556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.