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

V

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

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,410 participants in 2 patient groups

Colonoscopy (Standard of Care)
No Intervention group
Description:
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
CADe Device
Experimental group
Description:
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Treatment:
Device: Computer-Assisted Detection (CADe) Device

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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