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

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

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

Study Overview

• Status: Completed
• Conditions: Colonic Polyp
• Intervention / Treatment: Device: Colonoscopy

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 Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• Germany
  • Hanover, Germany
    • End- und Dickdarmzentrum Hannover
• Spain
  • Madrid, Spain
    • Hospital Universitario Ramon y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing screening or surveillance colonoscopy

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Videos and still images of the colonoscopy	Narrow band imaging (NBI) images and white-light images, video recordings of the colonoscopy	during the procedure

Collaborators and Investigators

• Sponsor: Olympus Europe SE & Co. KG
• Investigators: Principal Investigator: Sofía Parejo Carbonell, Hospital Universitario Ramon y Cajal

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Pathological Conditions, Signs and Symptoms; Colonic Polyps; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Colonoscopy
• Other Study ID Numbers: 2023-001 (University of Missouri)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No