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

Recruiting

• Conditions: Colonic Polyp

• Registration Number: NCT05869838
• Lead Sponsor: Olympus Europe SE & Co. KG

Brief 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.

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-22
• Study Start: 2024-03-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Videos and still images of the colonoscopy	during the procedure	Narrow band imaging (NBI) images and white-light images, video recordings of the colonoscopy

Trial Locations

Locations (3)

End- und Dickdarmzentrum Hannover; 🇩🇪 Hannover, Germany

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Ersta Hospital Stockholm; 🇸🇪 Stockholm, Sweden