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

Completed

• Conditions: Colorectal Cancer
• Interventions: Device: OIP-1

• Registration Number: NCT05943288
• Lead Sponsor: Olympus Europe SE & Co. KG

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-04-25
• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-13
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 850

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CADe +	OIP-1	Olympus Endoscopy Computer-Aided Detection (CADe) system

Primary Outcome Measures

Name	Time	Method
Adenoma Detection Rate (ADR)	During procedure	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).
Positive Predictive Value (PPV)	During procedure	Number of histologically confirmed polyps (i.e. adenomas, SSLs, or large (\>10mm) hyperplastic polyps divided by the total number of resections.

Secondary Outcome Measures

Name	Time	Method
Adenoma Per Colonoscopy (APC)	During procedure	Number of histologically proven adenomas (including advanced adenomas) or carcinomas divided by the total number of colonoscopies
Total Procedure Time	During procedure	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).
Endoscope withdrawal time	During procedure	Time from deepest point of insertion (cecum) needed for complete inspection of the colon, excluding time spent on therapeutic intervention.

Trial Locations

Locations (6)

ZU Leuven; 🇧🇪 Leuven, Belgium

Evangelisches Krankenhaus Düsseldorf; 🇩🇪 Düsseldorf, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Fundación Biomédica Galicia Sur; 🇪🇸 Pontevedra, Spain

Hospital Universitari I Politécnic La Fe; 🇪🇸 Valencia, Spain

Linköping Universitetssjukhus; 🇸🇪 Linköping, Sweden