Clinical Trial: Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prospective Randomized Trial to Compare the Clinical Efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
Brief 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 Summary:
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.
Sponsor: Smart Medical Systems Ltd.
Current Primary Outcome: G-EYE™ colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same. [ Time Frame: Approximalty following 14 days (histology results) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Number of polyp and adenoma detection, procedure times and safety (number of patients with adverse events. [ Time Frame: Up to 14 days (histology results) ]
Original Secondary Outcome: Same as current
Information By: Smart Medical Systems Ltd.
Dates:
Date Received: July 30, 2013
Date Started: May 2014
Date Completion:
Last Updated: October 25, 2016
Last Verified: October 2016
