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

March 14, 2024 updated by: Olympus Europe SE & Co. KG

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Hannover, Germany
        • Recruiting
        • End- und Dickdarmzentrum Hannover
        • Contact:
          • NA NA
  • Spain
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
          • NA NA
  • Sweden
      • Stockholm, Sweden
        • Not yet recruiting
        • Ersta Hospital Stockholm
        • Contact:
          • NA NA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olympus Europe SE & Co. KG

Investigators

  • Principal Investigator: Edgar Jaramillo Martínez, MD, Ersta Hospital Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

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 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-001

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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