NCT01917513

Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy

Prospective Randomized Trial to Compare the Clinical Efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (actual)
• 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 of G-EYE™ high definition colonoscopy with that of standard high definition colonoscopy

Detailed description

This is a multicenter, two-arm, randomized, open-label study intended to compare the detection rate obtained by performing G-EYE™ high definition colonoscopy vs. the detection rate obtained by performing high definition standard colonoscopy. The study will enroll 1000 subjects. 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. Subjects will sign informed consent form and undergo randomization. The study includes a run-in preliminary phase of 270 patients to allow physicians to get familiar with the G-EYE™ endoscope.

Conditions

• Adenoma
• Polyps
• Colorectal Cancer

Interventions

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

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2013-08-06
• Last updated: 2018-01-23
• Results posted: 2018-01-23

Locations

15 sites across 8 countries: United States, Denmark, Germany, India, Israel, Italy, Netherlands, United Kingdom