G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate-randomized Tandem Study With Different Endoscopist

Study Overview
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Brief Summary
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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
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Single Center, two-arm, randomized , open-label study with different and blinded endoscopists.

Official Title
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G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate - Randomized Tandem Study With Different Endoscopist

Conditions
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Adenoma, Colorectal Cancer

Intervention / Treatment
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* Procedure: Standard Colonoscopy
* Procedure: G-EYE(TM) 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 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)

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: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Subjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy | Procedure: Standard Colonoscopy<br>* Standard Colonoscopy<br>Procedure: G-EYE(TM) Colonoscopy<br>* G-EYE(TM) Colonoscopy<br>|
| Active Comparator: Group B<br>Subject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy | Procedure: Standard Colonoscopy<br>* Standard Colonoscopy<br>Procedure: G-EYE(TM) Colonoscopy<br>* G-EYE(TM) 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. |  | estimated 14 days (following histology results) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polyp and adenoma detection, procedure times and safety |  | 24-72 hours post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, Adenoma, Standard Colonoscopy, G-EYE(TM) Colonoscopy