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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-10-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Colon Adenoma Colon Polyp Colon Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Subjects, investigators, study site personnel, and pathologists will not be blinded to treatment assignments. All Verily personnel involved in the statistical analysis of this study will be blinded to treatment assignment. For the interim analysis, unblinded analysis will be performed by an independent statistician, the results of which will be communicated to a select group of Verily personnel not involved in the study management.

Study Groups

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Colonoscopy (Standard of Care)

The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

CADe Device

The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.

Group Type EXPERIMENTAL

Computer-Assisted Detection (CADe) Device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes