Safety and Efficacy of the Olympus CADe System in Real-time Colonoscopy

Study Overview
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Brief Summary
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This is a prospective, multicenter, randomized Trial to assess the safety and efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) system, OIP-1, in the detection of colorectal neoplasia's during real-time colonoscopy. The aim of this system is to improve physician performance in the detection of potential mucosal abnormalities during colonoscopy performed for primary Colorectal Cancer screening or postpolypectomy surveillance.

Detailed Description
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This Study aims to provide insight into whether the application of Artificial Intelligence (Olympus Endoscopy Computer-Aided Detection (CADe) system) increases the detection rate of adenomatous polyps in screening and / or surveillance colonoscopy procedures.

Official Title
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Safety and Efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) System in Detection of Colorectal Neoplasia's During Real-time Colonoscopy: A European Prospective, Multicenter, Randomized Controlled Trial (EuroCADe)

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Device: OIP-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent 45-80 years Undergoing colonoscopy for primary CRC screening or postpolypectomy surveillance Exclusion Criteria: Lack of informed written consent History of CRC or inflammatory bowel disease or polyposis syndrome / familial adenomatous polyposis coli (FAP) Prior failed colonoscopy multiple historic prior failed colonoscopy due to poor bowel preparation OR a single prior failed colonoscopy due to reasons other than poor bowel preparation Biopsy/anesthesia/sedation contraindications History of radio- and/or chemotherapy Concurrent participation in another competing clinical study

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CADe +<br>Olympus Endoscopy Computer-Aided Detection (CADe) system | Device: OIP-1<br>* Olympus Endoscopy Computer-Aided Detection (CADe) system<br>|
| CADe -<br>Standard of Care Endoscopy (HD Whitelight) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate (ADR) | Proportion of patients with at least one histologically confirmed adenoma (including advanced adenomas) or carcinoma in the CADe assisted colonoscopy (CADe+ arm) versus conventional colonoscopy without CAD (CADe- arm). | During procedure | 
| Positive Predictive Value (PPV) | Number of histologically confirmed polyps (i.e. adenomas, SSLs, or large (>10mm) hyperplastic polyps divided by the total number of resections. | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Per Colonoscopy (APC) | Number of histologically proven adenomas (including advanced adenomas) or carcinomas divided by the total number of colonoscopies | During procedure | 
| Total Procedure Time | Time from procedure start (insertion of the colonoscope) until colon inspection during a typical withdrawal from cecum to rectosigmoid including any time needed for interventional procedures (biopsies, resection). | During procedure | 
| Endoscope withdrawal time | Time from deepest point of insertion (cecum) needed for complete inspection of the colon, excluding time spent on therapeutic intervention. | During procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AI (Artificial Intelligence), CADe (Endoscopy Computer Aided Detection)