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Safety and Efficacy of the Olympus CADe System in Real-time Colonoscopy | Clinical Trials | Clareo Health

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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)

NCT05943288•Olympus Europe SE & Co. KG

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - 80 years

Sex

ALL

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

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

Key Dates

Start Date

April 25, 2023

Primary Completion Date

July 31, 2024

Completion Date

July 31, 2024

Last Updated

March 18, 2025

Enrollment

850

ACTUAL participants

Conditions

Colorectal Cancer

Interventions

OIP-1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors