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

December 19, 2024 updated by: Verily Life Sciences LLC
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1410

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Elisha Medical Center
      • Tel Aviv, Israel
        • Sourasky Medical Center (Ichilov)
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Health
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Susquehanna Research Group
    • Texas
      • El Paso, Texas, United States, 79912
        • ANRC Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Colonoscopy (Standard of Care)
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
Experimental: CADe Device
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in Adenomas Per Colonoscopy (APC)
Time Frame: Day 1
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)
Time Frame: Day 1
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adenoma Detection Rate (ADR)
Time Frame: Day 1
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.
Day 1
Mean Withdrawal and Inspection Time (MWT)
Time Frame: Day 1
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.
Day 1
Polyp Detection Rate (PDR)
Time Frame: Day 1
Polyp detection rate is defined as the proportion of patients with at least one histologically-confirmed polyp detected.
Day 1
Number of False Alerts Per Procedure
Time Frame: Day 1
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.
Day 1
Proximal Adenoma Detection Rate (pADR)
Time Frame: Day 1
pADR is defined as the percentage of patients with at least one histologically-confirmed adenoma detected in proximal colon.
Day 1
Flat Adenoma Detection Rate (fADR)
Time Frame: Day 1
fADR is defined as the percentage of patients with at least one histologically-confirmed non-polypoid adenoma detected.
Day 1
Serrated Lesions Per Colonoscopy (SLPC)
Time Frame: Day 1
SLPC is defined as the number of histologically confirmed serrated lesions detected, divided by the total number of colonoscopies.
Day 1
Serrated Lesions Detection Rate (SLDR)
Time Frame: Day 1
SLDR is defined as the percentage of patients with at least one histologically confirmed serrated lesion detected.
Day 1
Adenoma Detection Rate Including Carcinoma (ADR*)
Time Frame: Day 1
ADR* is defined as ADR, but also includes histologically-confirmed intramucosal carcinoma and adenocarcinoma.
Day 1
Small Adenoma Detection Rate (sADR)
Time Frame: Day 1
sADR is defined as the percentage of patients with at least one adenoma 5mm or smaller detected.
Day 1
Polyps Per Colonoscopy (PPC)
Time Frame: Day 1
PPC is defined as the total number of histologically-confirmed polyps found divided by the total number of colonoscopies performed, per study arm.
Day 1
Advanced Adenoma Detection Rate (aADR)
Time Frame: Day 1
aADR is defined as the percentage of patients with at least one adenoma ≥ 10 mm, or any adenoma < 10 mm, which was either of high-grade dysplasia (HGD) or villous or tubulovillous.
Day 1
False Positive Rate (FPR)
Time Frame: Day 1
FPR is defined as the proportion of colorectal lesions resected and biopsied and subsequently not histologically-confirmed to be clinically relevant colorectal polyps (e.g. a pathology finding of normal mucosa, inflammatory tissue, stool or debris, lymphoid aggregates).
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Verily Life Sciences LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Scooter Plowman, MD, Verily Life Sciences LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 103820

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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