Spots Global Cancer Trial Database for Comparison of Colonoscopy Adenoma Detection Yield

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Trial Identification

Brief Title: Comparison of Colonoscopy Adenoma Detection Yield

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

Study ID: NCT05158725

Conditions

Adenoma Colon

Interventions

Standard Colonoscopy

Discovery aided colonoscopy

Discovery and G-EYE

Study Description

Brief Summary: 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: 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.