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Prospective Image Collection of Colorectal Polyps. | Clinical Trials | Clareo Health

RECRUITING

Prospective Image Collection of Colorectal Polyps.

Multicenter Prospectively Collected Registry of Images and Videos of Colonic Lesions to Develop Artificial Intelligence to Predict Submucosal Invasion

NCT07401264•Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

Summary

It concerns a study in which we wish to collect images and corresponding histological information (microscopic characteristics) in a prospective manner in various European and non-European centers (multicentric). This means that the collection of images is new and happens in the context of a procedure that has not yet been carried out. The relevant procedure will involve a standard colonoscopy during which we wish to collect digital images and videos of large colorectal polyps (colorectal lesions). These images will later be used for the development of a new computer software (artificial intelligence) that is able to predict the histology (microscopic characteristics) and extent of invasion in the intestinal wall (submucosal invasion) all by itself. The latter is one of the goals in the European project ECOPOP in which the sponsor is involved.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Referral for standard or therapeutic colonoscopy
•Digital video material of standard colonoscopy containing at least one colorectal polyp (≥ 10mm) and/or with suspicion of malignancy/submucosal invasion
•Digital images of colorectal polyps ≥ 10mm made during standard colonoscopy and/or with suspicion of malignancy/submucosal invasion Page 11 of 21
•Videos and/or images can be made in white light or any virtual of dye-based enhancement technique
•Colonoscopies performed after IRB approval for this particular study.
•Material collected in adult patients of all sex or race, including pregnant women.

Exclusion Criteria

•Any contraindication to undergo a standard colonoscopy
•Any uncontrolled coagulopathy or bleeding disorder
•Colonoscopy videos not containing any or colorectal polyps \< 10mm
•Colonoscopy videos or images of low quality due to unstable imaging, stool remnants, bowel or patient movements or blurry vision
•Colonoscopy videos with visualization of the polyp less than 5 seconds due to unstable positioning, passing stool remnants, bowel or patient movements or blurry visions

Locations (1)

UZ Leuven

Leuven, Belgium

Key Dates

Start Date

April 7, 2022

Primary Completion Date

December 1, 2030

Completion Date

December 1, 2030

Last Updated

February 10, 2026

Enrollment

5,000

ESTIMATED participants

Conditions

Colonic Lesions

Contacts

Raf Bisschops, MD

CONTACT

+32 16 342161 raf.bisschops@uzleuven.be

Anja Luypaerts, CTA

CONTACT

+32 16 343357 anja.luypaerts@uzleuven.be

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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