Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Prospective Randomized Trial to Compare the Clinical Efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy

Conditions
-----------------
Adenoma, Polyps, Colorectal Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 50 years old Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits 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 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
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Approximalty following 14 days (histology results) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 14 days (histology results) | 

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