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

Primary Purpose

Colon Adenoma, Colon Polyp, Colon Lesion

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Computer-Assisted Detection (CADe) Device
Sponsored by
Verily Life Sciences LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colon Adenoma

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic
  • Duke Health
  • Great Lakes Gastroenterology Research
  • Susquehanna Research Group
  • ANRC Research
  • Elisha Medical Center
  • Sourasky Medical Center (Ichilov)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Colonoscopy (Standard of Care)

CADe Device

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
False Alert Rate (FAR)
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)
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)
Polyp detection rate is defined as the proportion of patients with at least one histologically-confirmed polyp detected.
Proximal Adenoma Detection Rate (pADR)
pADR is defined as the proportion of patients with at least one histologically-confirmed adenoma detected in proximal colon.
Flat Adenoma Detection Rate (fADR)
fADR is defined as the proportion of patients with at least one histologically-confirmed non-polypoid adenoma detected.
Serrated Lesions per Colonoscopy (SLPC)
SLPC is defined as the number of histologically confirmed serrated lesions detected, divided by the total number of colonoscopies.
Serrated Lesions Detection Rate (SLDR)
SLDR is defined as the proportion of patients with at least one histologically confirmed serrated lesion detected.
Adenoma Detection Rate including Carcinoma (ADR*)
ADR* is defined as ADR, but also includes histologically-confirmed intramucosal carcinoma and adenocarcinoma.
Small Adenoma Detection Rate (sADR)
sADR is defined as proportion of patients with at least one adenoma 5mm or smaller detected.
Polyps per colonoscopy (PPC)
PPC is defined as the total number of histologically-confirmed polyps found divided by the total number of colonoscopies performed, per study arm.
Advanced Adenoma Detection Rate (aADR)
aADR is defined as the proportion 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.
False Positive Rate (FPR)
FPR is defined as the proportion of colorectal lesions resected or 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).

Full Information

First Posted
February 25, 2022
Last Updated
November 28, 2022
Sponsor
Verily Life Sciences LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05275556
Brief Title
Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
Acronym
GAIN
Official Title
Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
October 28, 2022 (Actual)
Study Completion Date
October 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Verily Life Sciences LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenoma, Colon Polyp, Colon Lesion

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
1410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colonoscopy (Standard of Care)
Arm Type
No Intervention
Arm Description
The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care.
Arm Title
CADe Device
Arm Type
Experimental
Arm Description
The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device.
Intervention Type
Device
Intervention Name(s)
Computer-Assisted Detection (CADe) Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in Adenomas Per Colonoscopy (APC)
Description
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
Title
Difference in Positive Percent Agreement (PPA)
Description
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 Outcome Measure Information:
Title
Adenoma Detection Rate (ADR)
Description
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
Title
False Alert Rate (FAR)
Description
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
Title
Mean Withdrawal and Inspection Time (MWT)
Description
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.
Time Frame
Day 1
Title
Polyp Detection Rate (PDR)
Description
Polyp detection rate is defined as the proportion of patients with at least one histologically-confirmed polyp detected.
Time Frame
Day 1
Title
Proximal Adenoma Detection Rate (pADR)
Description
pADR is defined as the proportion of patients with at least one histologically-confirmed adenoma detected in proximal colon.
Time Frame
Day 1
Title
Flat Adenoma Detection Rate (fADR)
Description
fADR is defined as the proportion of patients with at least one histologically-confirmed non-polypoid adenoma detected.
Time Frame
Day 1
Title
Serrated Lesions per Colonoscopy (SLPC)
Description
SLPC is defined as the number of histologically confirmed serrated lesions detected, divided by the total number of colonoscopies.
Time Frame
Day 1
Title
Serrated Lesions Detection Rate (SLDR)
Description
SLDR is defined as the proportion of patients with at least one histologically confirmed serrated lesion detected.
Time Frame
Day 1
Title
Adenoma Detection Rate including Carcinoma (ADR*)
Description
ADR* is defined as ADR, but also includes histologically-confirmed intramucosal carcinoma and adenocarcinoma.
Time Frame
Day 1
Title
Small Adenoma Detection Rate (sADR)
Description
sADR is defined as proportion of patients with at least one adenoma 5mm or smaller detected.
Time Frame
Day 1
Title
Polyps per colonoscopy (PPC)
Description
PPC is defined as the total number of histologically-confirmed polyps found divided by the total number of colonoscopies performed, per study arm.
Time Frame
Day 1
Title
Advanced Adenoma Detection Rate (aADR)
Description
aADR is defined as the proportion 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.
Time Frame
Day 1
Title
False Positive Rate (FPR)
Description
FPR is defined as the proportion of colorectal lesions resected or 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).
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scooter Plowman, MD
Organizational Affiliation
Verily Life Sciences LLC
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Duke Health
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Great Lakes Gastroenterology Research
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Susquehanna Research Group
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
ANRC Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79912
Country
United States
Facility Name
Elisha Medical Center
City
Haifa
Country
Israel
Facility Name
Sourasky Medical Center (Ichilov)
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

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

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