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

NCT05275556 | Completed Results FDA Device

• 1 other identifier: 103820
• Study Type: interventional
• Target: 1,410
• Locations: 2 countries
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 1

Secondary Outcomes (13)

• Adenoma Detection Rate (ADR)

  Day 1

• Number of False Alerts Per Procedure

  Day 1

• Mean Withdrawal and Inspection Time (MWT)

  Day 1

• Polyp Detection Rate (PDR)

  Day 1

• Proximal Adenoma Detection Rate (pADR)

  Day 1

Study Arms (2)

Colonoscopy (Standard of Care)

NO INTERVENTION

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

CADe Device

EXPERIMENTAL

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

Device: Computer-Assisted Detection (CADe) Device

Interventions

Computer-Assisted Detection (CADe) Device 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.

CADe Device

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Verily Life Sciences LLC: lead

Study Sites (7)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Duke Health

Durham, North Carolina, 27710, United States

Location

Great Lakes Gastroenterology Research

Mentor, Ohio, 44060, United States

Location

Susquehanna Research Group

Camp Hill, Pennsylvania, 17011, United States

Location

ANRC Research

El Paso, Texas, 79912, United States

Location

Elisha Medical Center

Haifa, Israel

Location

Sourasky Medical Center (Ichilov)

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Scooter Plowman
• Organization: Verily

splowman@verily.com

650-861-9783

Study Officials

• Scooter Plowman, MD

  Verily Life Sciences LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 11, 2022
• Study Start: March 1, 2022
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2023-12

Locations

IL (2); US (5)