Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy

Study Overview
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Brief Summary
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The purpose of this study is to compare the adenoma detection rate (ADR) of the G-EYE™ colonoscopy with that of standard colonoscopy.

Detailed Description
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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.

Official Title
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Prospective Randomized Trial to Compare the Adenoma Detection Rate of G-EYE™ Colonoscopy With Standard Colonoscopy

Conditions
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Adenoma, Polyps, Colorectal Cancer

Intervention / Treatment
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* Device: G-EYE™ Colonoscopy
* Device: Standard Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 50 years old Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits, for diagnostic evaluation or for surveillance colonoscopy (history of adenoma resection). The patient must understand and provide written consent for the procedure. Exclusion Criteria: Subjects with inflammatory bowel disease; Subjects with a personal history of polyposis syndrome; Subjects with suspected chronic stricture potentially precluding complete colonoscopy; Subjects with diverticulitis or toxic megacolon; 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 that have not stopped using anticoagulants as required by the guidelines of the medical center; 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 Previous colonic surgery (except for appendectomy)

Ages Eligible for Study
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Minimum Age: 50 Years

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G-EYE™ Colonoscopy<br>G-EYE™ Colonoscopy | Device: G-EYE™ Colonoscopy<br>* G-EYE™ Colonoscopy<br>|
| Active Comparator: Standard Colonoscopy<br>Standard Colonoscopy | Device: Standard Colonoscopy<br>* Standard Colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| G-EYE™ Colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same |  | Approximately following 14 days (histology results) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 14 days (Histology results) | 
| Procedure times |  | At time of procedure | 
| Safety (number of patients with adverse events) |  | 48-72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenoma, Polyp, CRC, Colonoscopy, Detection Yield