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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05869838

Acronym

CODACO

Enrollment

600

Registered

2023-05-22

Start date

2024-03-12

Completion date

2025-10-30

Last updated

2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyp

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.

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.

Interventions

DEVICEColonoscopy

Screening or surveillance colonoscopy

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Germany, Spain

Contacts

PRINCIPAL_INVESTIGATORSofía Parejo Carbonell

Hospital Universitario Ramón y Cajal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026