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NCT05943288Completed

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)

Source: ClinicalTrials.gov · Last updated 18 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
850 (actual)
First submitted
7 Jun 2023
Start date
Apr 2023
Primary completion date
Jul 2024
Lead sponsor
Olympus Europe SE & Co. KG
NCT number
NCT05943288

What you commit to

  • Study type: Observational
  • Participants enrolled: 850
  • From Apr 2023 to the primary completion date, Jul 2024
  • 6 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Concurrent participation in another competing clinical study

Other illness

  • History of CRC or inflammatory bowel disease or polyposis syndrome / familial adenomatous polyposis coli (FAP)
  • History of radio- and/or chemotherapy

Other

  • Lack of informed written consent
  • Biopsy/anesthesia/sedation contraindications

Who the study is looking for

  • Signed informed consent
  • 45-80 years
  • Undergoing colonoscopy for primary CRC screening or postpolypectomy surveillance

Age in the registry: 45 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ZU Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumUnknown status
Evangelisches Krankenhaus Düsseldorf
Coordinator of this site? Confirm its status
DüsseldorfGermanyUnknown status
Universitätsklinikum Ulm
Coordinator of this site? Confirm its status
UlmGermanyUnknown status
Fundación Biomédica Galicia Sur
Coordinator of this site? Confirm its status
PontevedraSpainUnknown status
Hospital Universitari i Politécnic La Fe
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
Linköping Universitetssjukhus
Coordinator of this site? Confirm its status
LinköpingSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.