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

Colonic Polyp Clinical Trial

— CODACO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869838
• Other study ID #: 2023-001
• Status: Recruiting
• Start date: March 12, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Olympus Europe SE & Co. KG
• Contact: Swaantje Hoffstedt
• Phone: +49 40 23773 9351
• Email: swaantje.hoffstedt[@]olympus.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps

Intervention

Device:
• Colonoscopy
Screening or surveillance colonoscopy

Locations

Country	Name	City	State
Germany	End- und Dickdarmzentrum Hannover	Hannover
Spain	Hospital Universitario Ramón y Cajal	Madrid
Sweden	Ersta Hospital Stockholm	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Olympus Europe SE & Co. KG

Countries where clinical trial is conducted

Germany,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Videos and still images of the colonoscopy	Narrow band imaging (NBI) images and white-light images, video recordings of the colonoscopy	during the procedure