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

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)

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.

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.

Inclusion Criteria:

1. Signed informed consent
2. 45-80 years
3. Undergoing colonoscopy for primary CRC screening or postpolypectomy surveillance

Exclusion Criteria:

1. Lack of informed written consent

2. History of CRC or inflammatory bowel disease or polyposis syndrome / familial adenomatous polyposis coli (FAP)

3. 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

4. Biopsy/anesthesia/sedation contraindications

5. History of radio- and/or chemotherapy

6. Concurrent participation in another competing clinical study