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Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
NA trial testing Computer-Assisted Detection (CADe) Device in Colon Adenoma in 1,410 participants. Completed in 28 October 2022.
| Lead sponsor | Verily Life Sciences LLC |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | screening |
| Enrollment | 1,410 |
| Start date | 1 March 2022 |
| Primary completion | 28 October 2022 |
| Estimated completion | 28 October 2022 |
| Sites | 7 locations across United States, Israel |
Verily Life Sciences LLC — full company profile →
Adults 45 to 80, any sex, with Colon Adenoma or Colon Polyp. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy (Standard of Care) | 0.60 | 0.56 – 0.64 |
| CADe Device | 0.74 | 0.71 – 0.77 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy (Standard of Care) | 0.62 | 0.58 – 0.66 |
| CADe Device | 0.56 | 0.52 – 0.60 |
The Adenoma Detection Rate is defined as the number of patients with at least one histologically confirmed adenoma divided by the total number of patients enrolled per study arm.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy (Standard of Care) | 38.9 | 35.3 – 42.6 |
| CADe Device | 42.9 | 39.2 – 46.6 |
A false alert is defined as a bounding box that persists on the screen (approximately 2-3 seconds per the judgment of the colonoscopist) that is then determined by the colonoscopist not to contain a polyp. The false alert rate is calculated as the number of false alerts per procedure conducted in the intervention arm of the study.
| Group | Value | 95% CI |
|---|---|---|
| CADe Device | 417 |
The withdrawal time is defined as the time measured from the moment the withdrawal phase of the procedure begins (with the scope in the cecum) to the moment the scope is withdrawn from the patient. The Inspection time measurement will exclude washing and resection, and other peri-resection activity not deemed to be colonic inspection. Inspection times for both the control arm and intervention arm will be calculated retrospectively upon review of the video recordings.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy (Standard of Care) | 8.97 | ± 4.97 |
| CADe Device | 9.34 | ± 4.08 |
Polyp detection rate is defined as the proportion of patients with at least one histologically-confirmed polyp detected.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy (Standard of Care) | 364 | |
| CADe Device | 425 |
pADR is defined as the percentage of patients with at least one histologically-confirmed adenoma detected in proximal colon.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy (Standard of Care) | 198 | |
| CADe Device | 236 |
fADR is defined as the percentage of patients with at least one histologically-confirmed non-polypoid adenoma detected.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy (Standard of Care) | 19 | |
| CADe Device | 21 |
SLPC is defined as the number of histologically confirmed serrated lesions detected, divided by the total number of colonoscopies.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy (Standard of Care) | 0.34 | 0.30 – 0.38 |
| CADe Device | 0.46 | 0.42 – 0.50 |
SLDR is defined as the percentage of patients with at least one histologically confirmed serrated lesion detected.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy (Standard of Care) | 156 | |
| CADe Device | 219 |
ADR\* is defined as ADR, but also includes histologically-confirmed intramucosal carcinoma and adenocarcinoma.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy (Standard of Care) | 271 | |
| CADe Device | 307 |
sADR is defined as the percentage of patients with at least one adenoma 5mm or smaller detected.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy (Standard of Care) | 201 | |
| CADe Device | 236 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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