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

Verily Life Sciences LLC1,410 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

1,410

Conditions

Colon Adenoma Colon Polyp Colon Lesion

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (7)

Mayo Clinic

Rochester, Minnesota, United States

Duke Health

Durham, North Carolina, United States

Great Lakes Gastroenterology Research

Mentor, Ohio, United States

Susquehanna Research Group

Camp Hill, Pennsylvania, United States

Outcomes

Primary Outcomes

Difference in Adenomas Per Colonoscopy (APC)

Difference in Adenomas Per Colonoscopy (APC) between the control and intervention arm, evaluated for superiority. APC is defined as the average number of histologically confirmed adenomas resected per colonoscopy.

Time frame: Day 1

Difference in Positive Percent Agreement (PPA)

Difference in Positive Percent Agreement (PPA) between the control and intervention arm, evaluated for non-inferiority. PPA is defined as the total number of histologically confirmed Clinically Significant Excised Lesions, divided by the total number of excisions.

Time frame: Day 1

Secondary Outcomes

Adenoma Detection Rate (ADR)

The Adenoma Detection Rate is defined as the number of patients with at least one histologically confirmed adenoma divided by the total number of patients enrolled per study arm.

Time frame: Day 1

Number of False Alerts Per Procedure

A false alert is defined as a bounding box that persists on the screen (approximately 2-3 seconds per the judgment of the colonoscopist) that is then determined by the colonoscopist not to contain a polyp. The false alert rate is calculated as the number of false alerts per procedure conducted in the intervention arm of the study.

Time frame: Day 1

Mean Withdrawal and Inspection Time (MWT)

The withdrawal time is defined as the time measured from the moment the withdrawal phase of the procedure begins (with the scope in the cecum) to the moment the scope is withdrawn from the patient. The Inspection time measurement will exclude washing and resection, and other peri-resection activity not deemed to be colonic inspection. Inspection times for both the control arm and intervention arm will be calculated retrospectively upon review of the video recordings.

Data from ClinicalTrials.gov

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