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

NCT05275556 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1410

Last updated 2025-01-14

Study results available
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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.

Conditions

  • Colon Adenoma
  • Colon Polyp
  • Colon Lesion

Interventions

DEVICE

Computer-Assisted Detection (CADe) Device

The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making.

Sponsors & Collaborators

  • Verily Life Sciences LLC

    lead INDUSTRY

Principal Investigators

  • Scooter Plowman, MD · Verily Life Sciences LLC

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-10-28
Completion
2022-10-28
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05275556 on ClinicalTrials.gov