The purpose of this study is to compare the adenoma detection rate (ADR) of the G-EYE™ colonoscopy with that of standard colonoscopy.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
350
G-EYE™ Colonoscopy
Standard Colonoscopy
Bnai Zion Hospital
Haifa, Israel
RECRUITINGG-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)
Polyp and adenoma detection
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)
Procedure times
Time frame: At time of procedure
Safety (number of patients with adverse events)
Time frame: 48-72 hours
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