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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: OIP-1

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 Type: Observational
• Enrollment (Actual): 850

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • ZU Leuven
• Germany
  • Düsseldorf, Germany, 40217
    • Evangelisches Krankenhaus Düsseldorf
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm
• Spain
  • Pontevedra, Spain, 36071
    • Fundación Biomédica Galicia Sur
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
• Sweden
  • Linköping, Sweden, 58185
    • Linköping Universitetssjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects undergoing a colonoscopy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CADe +; Olympus Endoscopy Computer-Aided Detection (CADe) system	Device: OIP-1; Olympus Endoscopy Computer-Aided Detection (CADe) system
CADe -; Standard of Care Endoscopy (HD Whitelight)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	Device-, or procedure-related AEs and Serious AEs (SAEs) reported as incidence (%) and frequency (n).	During procedure
Non-neoplastic resection rate	Number of patients with no histological confirmation of adenoma, advanced adenoma, SSL, large hyperplastic polyp or carcinoma in any excised lesion divided by the number of colonoscopies where at least one polyp was resected	During procedure

Collaborators and Investigators

• Sponsor: Olympus Europe SE & Co. KG
• Collaborators: Cromsource
• Investigators: Study Director: Karolin Boecker, Olympus Europa SE & Co. KG

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: AI (Artificial Intelligence); CADe (Endoscopy Computer Aided Detection)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CIP2021-AI (OEKG)-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO