NCT02545699

Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy

Prospective Randomized Trial to Compare the Adenoma Detection Rate of G-EYE™ Colonoscopy With Standard Colonoscopy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Smart Medical Systems Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the adenoma detection rate (ADR) of the G-EYE™ colonoscopy with that of standard colonoscopy.

Detailed description

This is a single-center, two-arm , randomized, open-label study intended to compare the detection rate obtained by performing G-EYE™ colonoscopy vs. the detection rate obtained by performing standard colonoscopy. The study will enroll 350 subjects. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll in this randomized clinical study if the candidate meets the study inclusion and exclusion criteria. Subjects will sign an informed consent form and undergo randomization.

Conditions

• Adenoma
• Polyps
• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	G-EYE™ Colonoscopy	G-EYE™ Colonoscopy
DEVICE	Standard Colonoscopy	Standard Colonoscopy

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-09-10
• Last updated: 2016-06-07

Locations

1 site across 1 country: Israel