Comparison of Adenoma Detection Rate With ENDOCUFF VISION® vs. G-EYE®

Study Overview
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Brief Summary
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The study is intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV high definition colonoscopy.

Detailed Description
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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 ECV high definition colonoscopy.

Official Title
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A Prospective Randomized Comparison of Colonoscopy Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®) (Endocuff) Versus a Permanently Mounted Balloon (G-EYE®)

Conditions
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Adenoma, Colorectal Cancer

Intervention / Treatment
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* Device: ENDOCUFF VISION® device
* Device: G-EYE® colonoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Screening and surveillance population for Adenoma and CRC. The patient must understand and sign a written informed consent for the procedure. Exclusion Criteria: Subjects with inflammatory bowel disease; Subjects with a personal history of hereditary polyposis syndrome; Subjects with suspected chronic stricture potentially precluding complete colonoscopy; Subjects with diverticulitis or toxic megacolon; Subjects with prior colonic surgery (exclusion appendectomy) Subjects with a history of radiation therapy to abdomen or pelvis; Pregnant or lactating female subjects; Subjects who are currently enrolled in another clinical investigation. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) Any patient condition deemed too risky for the study by the investigator
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to one of two groups - ECV colonoscopy or G-EYE® colonoscopy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ECV colonoscopy<br>EndoCuff Vision® device (ECV) | Device: ENDOCUFF VISION® device<br>* ENDOCUFF VISION® is a disposable cap placed on the tip of a standard colonoscope, intended to flatten colonic folds and assist in controlling the colonoscope's field of view and tip positioning<br>|
| Experimental: G-EYE® colonoscopy<br>G-EYE® colonoscope (G-EYE) | Device: G-EYE® colonoscope<br>* The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between adenoma detection rate of G-EYE® colonoscopy and EndoCuff Vision® | G-EYE® colonoscopy adenoma detection rate will be compared to the adenoma detection rate of EndoCuff Vision® colonoscopy. The primary performance measure is the adenoma detection rate (ADR), which is defined as the percentage of subjects with at least one adenoma found, in each of the study groups. | June 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Adenoma