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A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies | Clinical Trials | Clareo Health

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A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies

Collecting Real-world Data on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies for the Development of a CAD (Computer Aided Detection) System: A Prospective, Multicenter, Post-market Investigation

NCT05869838•Olympus Europe SE & Co. KG

View on ClinicalTrials.gov

Summary

The objective of this study is to collect colonoscopy data for use in the development and testing of artificial intelligence (AI) devices for colonoscopies.

Detailed Description

The primary objective of this study is to collect colonoscopy data for use in the development and performance evaluation of AI devices. The data will be collected during routine colonoscopy procedures. Biopsy or resection will be performed if needed and all specimens will be sent for histopathological examination. The histopathological results will be recorded.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients aged 18 years or older
•Patients who have signed a written consent form from their voluntary decision after receiving thorough explanation on this study and fully understanding the explanation prior to participation in the study
•Patients who plan to receive colonoscopy procedure and meet any of the following conditions: Colon cancer screening, post-polypectomy surveillance, patients who are advised by a physician to take a colonoscopy exam

Exclusion Criteria

•Patients for whom endoscopic submucosal dissection is planned
•Patients for whom polypectomy is difficult to perform due to antithrombotic therapy received etc.
•Patients who have to receive an urgent colonoscopy procedure
•Patients who underwent total colectomy of the large intestine
•Patients who are judged by a physician to be contraindicated for colonoscopy procedures
•Patients who have participated in another clinical study within the last 30 days

Locations (2)

End- und Dickdarmzentrum Hannover

Hanover, Germany

Hospital Universitario Ramón y Cajal

Madrid, Spain

Key Dates

Start Date

March 12, 2024

Primary Completion Date

October 30, 2025

Completion Date

October 30, 2025

Last Updated

March 6, 2026

Enrollment

600

ACTUAL participants

Conditions

Colonic Polyp

Interventions

Colonoscopy

DEVICE

Training Physicians to Differentiate the Paris Classification Using Artificial Colon Polyp Images

NCT06550908

Colonic PolypColon Adenoma

View study

RECRUITINGNA

Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference

NCT07089615

Colonic Polyps

View study

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 6, 2026Data 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.

View ClinicalTrials.gov Terms and Conditions

A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies

Inclusion Criteria

Exclusion Criteria

Training Physicians to Differentiate the Paris Classification Using Artificial Colon Polyp Images

Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference

Effective Withdrawal Time and Adenoma Detection Rate

Computer Aided Polyp Detection (C3PO) Trial

Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial

Comparison Rectal Endoscopic Submucosal Dissection to Endoscopic Mucosal Resection