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

Sponsor
Olympus Europe SE & Co. KG (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05869838
Collaborator
(none)
600
Enrollment
3
Locations
11
Anticipated Duration (Months)
200
Patients Per Site
18.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Videos and still images of the colonoscopy [during the procedure]

    Narrow band imaging (NBI) images and white-light images, video recordings of the colonoscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 End- und Dickdarmzentrum Hannover Hannover Germany
2 Hospital Universitario Ramón y Cajal Madrid Spain
3 Ersta Hospital Stockholm Stockholm Sweden

Sponsors and Collaborators

  • Olympus Europe SE & Co. KG

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olympus Europe SE & Co. KG
ClinicalTrials.gov Identifier:
NCT05869838
Other Study ID Numbers:
  • 2023-001
First Posted:
May 22, 2023
Last Update Posted:
May 22, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Colonic Polyps

Study Results

No Results Posted as of May 22, 2023