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Prospective Randomized Trial to Compare the Clinical Efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
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
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.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, United States
NYU Langone Medical Center
New York, New York, United States
Herlev Hospital
Harlev, Denmark
Universitätsmedizin Johannes Gutenberg University Mainz
Mainz, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Helios Dr. Horst Schmidt Kliniken (HSK)
Wiesbaden, Germany
Asian Institute of Gastroenterology
Hyderabad, India
Hadassah Medical Center
Jerusalem, Israel
Laniado Hospital
Netanya, Israel
Assaf Harofeh Medical Center
Tzrifin, Israel
Start Date
May 1, 2014
Primary Completion Date
September 1, 2016
Completion Date
September 1, 2016
Last Updated
January 23, 2018
1,000
ACTUAL participants
G-EYE™ colonoscopy
DEVICE
Standard Colonoscopy
DEVICE
Lead Sponsor
Smart Medical Systems Ltd.
NCT06696768
NCT04704661
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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