NCT05237310

Comparing Detection of Standard Colonoscopy, CAD-EYE and Combined CAD-EYE and G-EYE® Aided Colonoscopy

Dual Tandem Study Comparing the Adenoma Detection and Miss-rate of Standard Colonoscopy to That of Artificial Intelligence (CAD-EYE) and to That of Artificial Intelligence (CAD-EYE) and G-EYE® Aided Colonoscopy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 372 (estimated)
• Sponsor: Smart Medical Systems Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy.

Detailed description

The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy. This is a single-center, four-arm dual-tandem, randomized, open-label study intended to compare the additional detection yield beyond standard colonoscopy obtained by performing combined CAD-EYE and G-EYE® high definition colonoscopy vs. the additional detection yield beyond standard colonoscopy obtained by performing CAD-EYE high definition colonoscopy. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll into this randomized clinical study if the candidate meets the study inclusion and exclusion criteria

Conditions

• Colorectal Cancer
• Adenoma

Interventions

Type	Name	Description
DEVICE	Standard Colonoscopy	Standard Colonoscopy using a standard Fujifilm colonoscope
DEVICE	G-EYE Colonoscopy	G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope
DEVICE	CAD-EYE	Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence

Timeline

• Start date: 2022-02-02
• Primary completion: 2022-08-01
• Completion: 2022-09-01
• First posted: 2022-02-14
• Last updated: 2022-03-08

Locations

1 site across 1 country: Germany