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

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.

Study Overview

• Status: Recruiting
• Conditions: Colonic Lesions

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Raf Bisschops, MD; Phone Number: +32 16 342161; Email: raf.bisschops@uzleuven.be
• Study Contact Backup: Name: Anja Luypaerts, CTA; Phone Number: +32 16 343357; Email: anja.luypaerts@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Raf Bisschops, MD; Phone Number: +32 16 342161; Email: raf.bisschops@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

patients who need a standard or therapeutic colonoscopy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
registry of images of colonic lesions	5 year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: image registry
• Other Study ID Numbers: S65253

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No