Clinical Trial: Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Prospective Randomized Trial to Compare the Adenoma Detection Rate of G-EYE™ Colonoscopy With Standard Colonoscopy
Brief 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 Summary:
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.
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: Approximately following 14 days (histology results) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Polyp and adenoma detection [ Time Frame: Up to 14 days (Histology results) ]The secondary outcome is a composite- each of the measured parameters will be reported as a single value for each arm.
- Procedure times [ Time Frame: At time of procedure ]
- Safety (number of patients with adverse events) [ Time Frame: 48-72 hours ]
Original Secondary Outcome: Same as current
Information By: Smart Medical Systems Ltd.
Dates:
Date Received: August 31, 2015
Date Started: September 2015
Date Completion: June 2017
Last Updated: June 5, 2016
Last Verified: June 2016
