A Prospective Randomized Study Comparing the Adenoma Detection Yield of SC, AI and Combined AI and G-EYE®

Study Overview
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Brief Summary
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This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy

Detailed Description
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This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy Study aim is to compare the adenoma detection yield, expressed by Adenoma Per Colonoscopy (APC), of these 3 arms.

Official Title
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A Prospective Randomized Study Comparing the Adenoma Detection Yield of (i) Standard Colonoscopy (SC), (ii) Artificial Intelligence (GI Genius™) (AI), and (Iii) Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy

Conditions
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Colorectal (Colon or Rectal) Cancer, Adenoma

Intervention / Treatment
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* Device: Standard Colonoscopy
* Device: Artificial Intelligence Aided Colonoscopy (GI Genius™)
* Device: Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of age ≥ 45 years old Referred to colonoscopy for screening or 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, 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 Previous colonic surgery (except for appendectomy)

Ages Eligible for Study
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Minimum Age: 45 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: Parallel Assignment
Interventional Model Description: This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy, (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™), and (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Colonoscopy (SC)<br>Subjects enrolled to arm 1 (SC) will undergo colonoscopy using a standard colonoscope. | Device: Standard Colonoscopy<br>* Subjects randomized into arm 1 will undergo standard colonoscopy using a standard colonoscope<br>|
| Active Comparator: Artificial Intelligence Aided Colonoscopy (GI Genius™) (AI)<br>Subjects enrolled to arm 2 (AI) will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™) | Device: Artificial Intelligence Aided Colonoscopy (GI Genius™)<br>* Subjects randomized into arm 2 will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)<br>|
| Experimental: Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG)<br>Subjects enrolled to arm 3 (AG) will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™). | Device: Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy<br>* Subjects enrolled to arm 3 (AG) will undergo colonoscopy using the G-EYE® Colonoscope and Artificial Intelligence Aided Colonoscopy (GI Genius™).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Per Colonoscopy (APC) (AI compared with AG) | Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of AI compared with APC of AG. | Upon histology results (up to 30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Per Colonoscopy (APC) (SC compared with AG) | Adenoma detection yield, represented by Adenoma Per Colonoscopy (APC) of SC compared with APC of AG | Upon histology results (up to 30 days) | 
| Advanced Adenoma Per Colonoscopy (AAPC) (SC compared with AG) | Advanced Adenoma detection yield, represented by Advanced Adenoma Per Colonoscopy (AAPC) of SC compared with AAPC of AG | Upon histology results (up to 30 days) |