Clinical Trial: G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate-randomized Tandem Study With Different Endoscopist

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate - Randomized Tandem Study With Different Endoscopist

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: Single Center, two-arm, randomized , open-label study with different and blinded endoscopists.
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: estimated 14 days (following histology results) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: polyp and adenoma detection, procedure times and safety [ Time Frame: 24-72 hours post procedure ]

Original Secondary Outcome: Same as current

Information By: Smart Medical Systems Ltd.

Dates:
Date Received: February 10, 2014
Date Started: November 2013
Date Completion:
Last Updated: February 11, 2016
Last Verified: February 2016