CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,410 enrolled
Drug / intervention
Computer-Assisted Detection (CADe) Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05275556
NCT05275556N/ACompleted
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Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)

Verily Life Sciences LLC·interventional·Posted Mar 11, 2022·Updated Jan 14, 2025

In Brief

A clinical study evaluating Computer-Assisted Detection (CADe) Device for Colon Adenoma and 2 related conditions. Completed, enrolled 1,410 participants across 7 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColon Adenoma, Colon Polyp, Colon Lesion
CountriesIsrael, United States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 11, 2022
Enrollment StartMar 1, 2022
Primary CompletionOct 28, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.3 years ago

Interventions

Computer-Assisted Detection (CADe) Devicedevice

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.