A Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care (White Light )

Study Overview
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Brief Summary
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This study is to assess the sensitivity and added benefits of CADEYE compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

Detailed Description
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Failure in polyp recognition is a major determinant for the high rate of missed colorectal neoplasms. In response, technological advances have paved the way for Computer-Aided Polyp Detection (CAD-e) systems. Artificial intelligence systems allow of real-time computer- aided detection of polyps with high-accuracy. CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure. The data generated from this study will provide an estimate of the ADR throughout the Middle East as well as assess the accuracy of CADEYE in detecting adenomas in comparison to standard of care.

Official Title
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A Multi-center Control Study to Determine the Efficacy of CADEYE in Detecting Colon Polyps in Comparison to Standard of Care

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: CAD EYE (Computer Aided Diagnosis ----?


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40-80 years old subjects Subjects undergoing colonoscopy for the following: o Primary CRC screening Post-polypectomy surveillance Work up following FIT positivity Symptoms/signs suspicions of CRC Subjects must be willing to give written informed consent for the trial Exclusion Criteria: Unable to consent Contraindicated to undergo endoscopy Hospitalized patient Patients with the following conditions: History of colon resection History of CRC Antithrombotic therapy precluding colon resection o Inflammatory Bowel Disease (IBD) Familial Adenomatous Polyposis (FAP) Pregnant or lactating Poor bowel preparation: BBPS 0 or 1 in a segment

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Patients undergoing White Light Endoscopy (standard of care)<br>All subjects in Experimental Arm A will undergo SOC (white-light endoscopy). | |
| Experimental: Patients undergoing CAD EYE endoscopy<br>All subjects in Experimental Arm B will undergo CADEYE endoscopy. | Diagnostic Test: CAD EYE (Computer Aided Diagnosis ----?<br>* CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure and and allows a real time computer aided detection of polyps with high accuracy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | Adenoma detection rate is the primary end point which is the percentage of patients with at least 1 histologically proven adenoma or carcinoma. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenomas detected per colonoscopy |  | 1 year | 
| Proximal Adenoma detection rate |  | 1 year | 
| Withdrawal time |  | 1 year | 
| Non-neoplastic detection rate |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer screening