Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06505304

AI-enabled Endoscopic Prediction of Post-operative Recurrence in Crohn's Disease

Led by University College Cork · Updated on 2024-07-18

225

Participants Needed

15

Research Sites

108 weeks

Total Duration

On this page

Sponsors

U

University College Cork

Lead Sponsor

T

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 of high-risk patients who can potentially benefit from early treatments to halt the progression of Crohn's disease (CD). The investigators will develop a novel endoscopic assessment system using endoscopic enhanced imaging (EEI) to evaluate early post-surgical changes and predict post-operative CD recurrence (POCr). By integrating with immune marker profiling, clinical data, and AI assessment of EEI and histology, the investigators further plan to improve risk stratification and reduce interobserver variability.

CONDITIONS

Official Title

AI-enabled Endoscopic Prediction of Post-operative Recurrence in Crohn's Disease

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 18 years and 75 years.
  • Established diagnosis of Crohn's disease at least six months prior to study.
  • Patients who have undergone intestinal resection within 3 months before study entry or have surgery planned.
Not Eligible

You will not qualify if you...

  • Unable to provide consent.
  • Serious co-morbidities posing clinical contraindication.
  • Presence of an ostomy.
  • Currently pregnant or breastfeeding.
  • Contraindications for colonoscopy or biopsies.
  • Boston Bowel Preparation Scale Score less than 2 in the rectum plus left-sided colon.
  • Allergy to nuts or shellfish (exclusion for confocal laser endomicroscopy only).
  • Severe or uncontrolled asthma (exclusion for confocal laser endomicroscopy only).
  • Use of beta blockers (exclusion for confocal laser endomicroscopy only).
  • Previous reaction to fluorescein (exclusion for confocal laser endomicroscopy only).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

University of Leuven

Leuven, Belgium

Active, Not Recruiting

2

University of Calgary

Calgary, Canada

Actively Recruiting

3

University Hospital Erlangen

Erlangen, Germany

Active, Not Recruiting

4

Cork University Hospital

Cork, Ireland

Active, Not Recruiting

5

Mercy University Hospital

Cork, Ireland

Active, Not Recruiting

6

University College Dublin

Dublin, Ireland

Actively Recruiting

7

University College Hospitals Galway

Galway, Ireland

Active, Not Recruiting

8

Rabin Medical Centre

Tel Aviv, Israel

Actively Recruiting

9

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Active, Not Recruiting

10

ASST Spedali Civili

Brescia, Italy

Active, Not Recruiting

11

ASST Fatebenefratelli Sacco

Milan, Italy

Actively Recruiting

12

IRCCS Cà Granda Ospedale Maggiore

Milan, Italy

Actively Recruiting

13

University Vita-Salute San Raffaele

Milan, Italy

Active, Not Recruiting

14

University Federico II

Naples, Italy

Actively Recruiting

15

IRCCS San Matteo

Pavia, Italy

Actively Recruiting

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Research Team

M

Michelle O'Riordan

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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