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

Last updated: March 17, 2025
Sponsor: Olympus Europe SE & Co. KG
Overall Status: Completed

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer

Cancer

Treatment

OIP-1

Clinical Study ID

NCT05943288
CIP2021-AI (OEKG)-01
  • Ages 45-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed informed consent

  2. 45-80 years

  3. Undergoing colonoscopy for primary CRC screening or postpolypectomy surveillance

Exclusion

Exclusion Criteria:

  1. Lack of informed written consent

  2. History of CRC or inflammatory bowel disease or polyposis syndrome / familialadenomatous 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 bowelpreparation

  1. Biopsy/anesthesia/sedation contraindications

  2. History of radio- and/or chemotherapy

  3. Concurrent participation in another competing clinical study

Study Design

Total Participants: 850
Treatment Group(s): 1
Primary Treatment: OIP-1
Phase:
Study Start date:
April 25, 2023
Estimated Completion Date:
July 31, 2024

Study 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.

Connect with a study center

  • ZU Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Evangelisches Krankenhaus Düsseldorf

    Düsseldorf, 40217
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Fundación Biomédica Galicia Sur

    Pontevedra, 36071
    Spain

    Site Not Available

  • Hospital Universitari I Politécnic La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Linköping Universitetssjukhus

    Linköping, 58185
    Sweden

    Site Not Available

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