Comparing Detection of Standard Colonoscopy, CAD-EYE and Combined CAD-EYE and G-EYE® Aided Colonoscopy

Study Overview
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Brief Summary
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The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy.

Detailed Description
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The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy. This is a single-center, four-arm dual-tandem, randomized, open-label study intended to compare the additional detection yield beyond standard colonoscopy obtained by performing combined CAD-EYE and G-EYE® high definition colonoscopy vs. the additional detection yield beyond standard colonoscopy obtained by performing CAD-EYE high definition colonoscopy. 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

Official Title
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Dual Tandem Study Comparing the Adenoma Detection and Miss-rate of Standard Colonoscopy to That of Artificial Intelligence (CAD-EYE) and to That of Artificial Intelligence (CAD-EYE) and G-EYE® Aided Colonoscopy

Conditions
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Colorectal Cancer, Adenoma

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Screening and surveillance population for Adenoma and CRC. Subjects age is at least 18 years 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

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Subjects will be randomized to one of four groups (arms), Group A1, A2, B1 and B2: Group A1: Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group A2: Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group B1: Subjects will undergo standard colonoscopy immediately followed by combined CAD-EYE and G-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group B2: Subjects will undergo combined CAD-EYE and G-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Colonoscopy followed by CAD-EYE<br>Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). | Device: Standard Colonoscopy<br>* Standard Colonoscopy using a standard Fujifilm colonoscope<br>Device: CAD-EYE<br>* Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence<br>|
| Active Comparator: CAD-EYE followed by Standard Colonoscopy<br>Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). | Device: Standard Colonoscopy<br>* Standard Colonoscopy using a standard Fujifilm colonoscope<br>Device: CAD-EYE<br>* Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence<br>|
| Active Comparator: Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy<br>Subjects will undergo standard colonoscopy immediately followed by combined CAD-EYE and G-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). | Device: Standard Colonoscopy<br>* Standard Colonoscopy using a standard Fujifilm colonoscope<br>Device: G-EYE Colonoscopy<br>* G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope<br>Device: CAD-EYE<br>* Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence<br>|
| Active Comparator: Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy<br>Subjects will undergo combined CAD-EYE and G-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). | Device: Standard Colonoscopy<br>* Standard Colonoscopy using a standard Fujifilm colonoscope<br>Device: G-EYE Colonoscopy<br>* G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope<br>Device: CAD-EYE<br>* Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional Adenoma Detection | Additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard colonoscopy compared to the additional adenoma detection yield of CAD-EYE aided colonoscopy over standard colonoscopy | Upon histology results (up to 30 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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G-EYE, Colonoscopy, CAD-EYE, Adenoma, Colorectal Cancer