UZ Leuven
Leuven, 3000, Belgium
Location status: Recruiting
Recruiting
NCT Number: NCT07401264
Prospective Image Collection of Colorectal Polyps.
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
registry of images of colonic lesions
Time frame: 5 year
Study contacts
Contact information is provided by the study sponsor or research team.
Anja Luypaerts, CTA
CONTACT
Raf Bisschops, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Other
Registry information
Official study title
Multicenter Prospectively Collected Registry of Images and Videos of Colonic Lesions to Develop Artificial Intelligence to Predict Submucosal Invasion
Important dates
- Study start
- 2022
- Primary completion
- 2030
- Study completion
- 2030
- First posted
- Feb 10, 2026
- Registry last updated
- Feb 10, 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.