Status:
RECRUITING
AI-enabled Endoscopic Prediction of Post-operative Recurrence in Crohn's Disease
Lead Sponsor:
University College Cork
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
Conditions:
Crohn Disease
Eligibility:
All Genders
18-75 years
Brief Summary
This is a multicentre prospective international observational study. This study aims to introduce a novel multidimensional approach to precision imaging, enabling the identification and stratification...
Detailed Description
Background: Up to 70% of Crohn's disease (CD) patients will undergo a surgical resection in their lifetime. However, surgery is non-curative since 50% of patients have a recurrence, and about one-thi...
Eligibility Criteria
Inclusion
- Patients aged between 18 years and 75 years.
- Established diagnosis of CD at least six months prior to study.
- Patients who have undergone intestinal resection within 3 months before study entry or have surgery planned.
Exclusion
- Inability to provide consent.
- Presence of serious co-morbidities (clinical contraindication).
- Presence of ostomy.
- Pregnancy or breastfeeding.
- Contraindication for colonoscopy or biopsies.
- Boston Bowel Preparation Scale Score \<2 in the rectum plus left-sided colon.
- Exclusion criteria for pCLE only:
- Allergy to nuts or shellfish.
- Severe or uncontrolled asthma.
- Use of beta blockers.
- Previous history of reaction to fluorescein.
- Patients excluded from pCLE can still enter the study and undergo only standard-of-care endoscopy.
Key Trial Info
Start Date :
May 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT06505304
Start Date
May 1 2024
End Date
May 31 2026
Last Update
July 18 2024
Active Locations (15)
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1
University of Leuven
Leuven, Belgium
2
University of Calgary
Calgary, Canada
3
University Hospital Erlangen
Erlangen, Germany
4
Cork University Hospital
Cork, Ireland