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

Sponsor

Verily Life Sciences LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05275556

Collaborator

(none)

1,200

Enrollment

Locations

Arms

Anticipated Duration (Months)

300

Patients Per Site

37.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, multicenter, randomized controlled study to evaluate the effect of the Computer-Assisted Detection (CADe) Device on Adenoma Detection Rate 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.

Condition or Disease	Intervention/Treatment	Phase
Colon Adenoma Colon Polyp Colon Lesion	Device: Computer-Assisted Detection (CADe) Device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Difference in Adenoma Detection Rate (ADR) [Day 1]
Difference in Adenoma Detection Rate (ADR) between the control and intervention arm, evaluated for superiority
Difference in Positive Percent Agreement (PPA) [Day 1]
Difference in Positive Percent Agreement (PPA) between the control and intervention arm, evaluated for non-inferiority

Secondary Outcome Measures

Adenomas Per Colonoscopy (APC) [Day 1]
The Adenoma Per Colonoscopy rate is defined as the total number of histologically-confirmed adenomas (as defined in the co-primary endpoint) divided by the total number of colonoscopies performed, per study arm.
False Alert Rate (FAR) [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.
Mean Withdrawal and Inspection Time (MWT) [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.
Polyp Detection Rate (PDR) [Day 1]
Polyp detection rate is defined as the proportion of patients with at least one histologically-confirmed polyp detected.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905
2	Susquehanna Research Group	Camp Hill	Pennsylvania	United States	17011
3	ANRC Research	El Paso	Texas	United States	79912
4	Elisha Medical Center	Haifa		Israel

Sponsors and Collaborators

Verily Life Sciences LLC

Investigators

Study Director: Scooter Plowman, MD, Verily Life Sciences LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Verily Life Sciences LLC

ClinicalTrials.gov Identifier:

NCT05275556

Other Study ID Numbers:

103820

First Posted:

Mar 11, 2022

Last Update Posted:

Jul 5, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Adenoma

Polyps

Study Results

No Results Posted as of Jul 5, 2022