Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 2:10 AM
Study NCT ID:
NCT05275556
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2022-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
Sponsor:
Verily Life Sciences LLC
Organization:
Study Overview
Official Title:
Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAIN
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: