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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,000
G-EYE™ colonoscopy
Standard Colonoscopy
Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, United States
NYU Langone Medical Center
New York, New York, United States
Herlev Hospital
Detection Rate of Adenomas and Serrated Lesions
The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group
Time frame: Approximalty following 14 days (histology results)
Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events.
The secondary outcome is a composite-each of the measured parameters will be reported as a single value for each arm
Time frame: Up to 14 days (histology results)
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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
...and 5 more locations