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OpenTrials
Completed

NCT Number: NCT05869838

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

End- und Dickdarmzentrum Hannover, Hanover, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colonoscopy

Device

Screening or surveillance colonoscopy

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Olympus Europe SE & Co. KG

Industry

Registry information

Official study 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

Acronym: CODACO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 22, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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