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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colon Adenoma, Colon Polyp, Colon Lesion

Intervention / Treatment
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* Device: Computer-Assisted Detection (CADe) Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Colonoscopy (Standard of Care)<br>The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | |
| Experimental: CADe Device<br>The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. | Device: Computer-Assisted Detection (CADe) Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 
| 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. | 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. | Day 1 | 
| Polyp Detection Rate (PDR) | Polyp detection rate is defined as the proportion of patients with at least one histologically-confirmed polyp detected. | Day 1 | 
| Proximal Adenoma Detection Rate (pADR) | pADR is defined as the proportion of patients with at least one histologically-confirmed adenoma detected in proximal colon. | Day 1 | 
| Flat Adenoma Detection Rate (fADR) | fADR is defined as the proportion of patients with at least one histologically-confirmed non-polypoid adenoma detected. | Day 1 | 
| Serrated Lesions per Colonoscopy (SLPC) | 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) | SLDR is defined as the proportion of patients with at least one histologically confirmed serrated lesion detected. | Day 1 | 
| Adenoma Detection Rate including Carcinoma (ADR*) | ADR* is defined as ADR, but also includes histologically-confirmed intramucosal carcinoma and adenocarcinoma. | Day 1 | 
| Small Adenoma Detection Rate (sADR) | sADR is defined as proportion of patients with at least one adenoma 5mm or smaller detected. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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). | Day 1 |