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

Olympus

Status: Completed

Conditions: Colorectal Cancer

Treatments: Device: OIP-1

Study type: Observational

Funder types: Industry

Identifiers

NCT05943288

CIP2021-AI (OEKG)-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 850 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

850 participants in 2 patient groups

CADe +

Description:

Olympus Endoscopy Computer-Aided Detection (CADe) system

Treatment:

Device: OIP-1

CADe -

Description:

Standard of Care Endoscopy (HD Whitelight)