Comparison of Colonoscopy Adenoma Detection Yield

Study Overview
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Brief Summary
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A Prospective Randomized Comparison of colonoscopy Adenoma Detection Yield of (i) Standard Colonoscopy (SC), (ii) artificial intelligence (Discovery) aided colonoscopy, and (iii) artificial intelligence (Discovery) and permanently mounted balloon (G-EYE®) aided colonoscopy.

Detailed Description
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Multi-center, three-arm, randomized, controlled, open-label study. Total of up to 1320 patients will be randomized, including up to 10% for subject drop-out, 440 to each of the three following arms (groups): Group 1 (1st arm): patients will receive standard colonoscopy (SC) Group 2 (2nd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software (DC) Group 3 (3rd arm): patients will receive colonoscopy aided by the Discovery artificial intelligence software and the G-EYE® balloon (GDC) The purpose of this study is to compare between the diagnostic yield of Standard Colonoscopy, Discovery aided colonoscopy, and Discovery & G-EYE® aided colonoscopy.

Official Title
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Comparison of Colonoscopy Adenoma Detection Yield of Standard Colonoscopy, Discovery Aided Colonoscopy, and Discovery and G-EYE® Aided Colonoscopy

Conditions
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Adenoma Colon

Intervention / Treatment
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* Device: Standard Colonoscopy
* Device: Discovery aided colonoscopy
* Device: Discovery and G-EYE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Screening and surveillance population for Adenoma and CRC. The patient must understand and sign a written informed consent for the procedure. Exclusion Criteria: Subjects with inflammatory bowel disease; Subjects with a personal history of hereditary polyposis syndrome; Subjects with suspected chronic stricture potentially precluding complete colonoscopy; Subjects with diverticulitis or toxic megacolon; Subjects with prior colonic surgery (exclusion appendectomy) Subjects with a history of radiation therapy to abdomen or pelvis; Pregnant or lactating female subjects; Subjects who are currently enrolled in another clinical investigation. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) Any patient condition deemed too risky for the study by the investigator
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: Crossover Assignment
Interventional Model Description: Multi-center, three-arm, randomized, controlled, open-label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Colonoscopy<br>Subjects will undergo colonoscopy using a standard colonoscope | Device: Standard Colonoscopy<br>* In this arm, subjects will undergo colonoscopy using a standard colonoscope<br>|
| Active Comparator: Discovery aided colonoscopy<br>Subjects will undergo colonoscopy using a a standard colonoscope and the Discovery aided colonoscopy | Device: Discovery aided colonoscopy<br>* the Discovery is a customized detection support software, developed utilizing AI deep learning technology to support endoscopic lesion detection in the colon. In this arm, a standard colonoscope is used with the Discovery.<br>|
| Experimental: Discovery and G-EYE aided colonoscopy<br>Subjects will undergo colonoscopy using the G-EYE Endoscope and the Discovery aided colonoscopy | Device: Discovery and G-EYE<br>* The G-EYE® Endoscope is a standard colonoscope which is remanufactured by installing the G-EYE® balloon on the distal bending section of the colonoscope. in this arm, the G-EYE® Endoscope is used with the Discovery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection yield | adenoma detection yield, represented by Adenoma Per Colonoscopy (APC), of Standard Colonoscopy, compared with APC of Discovery aided colonoscopy and further compared with APC of Discovery & G-EYE® aided colonoscopy | Upon histology results (up to 30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate (Discovery + G-EYE vs. Standard Colonoscopy) | Adenoma Detection Rate of Discovery and G-EYE® aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy | Upon histology results (up to 30 days) | 
| Adenoma Detection Rate (Discovery vs. Standard Colonosocopy) | Adenoma Detection Rate of Discovery aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy | Upon histology results (up to 30 days) | 
| Adenoma Per Colonoscopy (Discovery vs. Discovery + G-EYE) | Adenoma Per Colonoscopy of Discovery aided colonoscopy compared to Adenoma Per Colonoscopy of Discovery and G-EYE® aided colonoscopy | Upon histology results (up to 30 days) |