NCT02238665CompletedNot Applicable
CLE for Differential Diagnosis of IBD
University of Erlangen-Nürnberg Medical School1 site in 1 country105 target enrollmentStarted: October 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Number of participants with IBD
Study Overview
Brief Summary
Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on demand in vivo characterization of architectural and cellular details during endoscopy. Here, we assessed the efficacy of CLE to differentiate between UC and CD.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •equal or above 18 years of age
- •ability to provide written informed consent
- •well-established diagnosis of CD or UC
Exclusion Criteria
- •history of IBD reclassification in the last 3 years
- •Boston Bowel Preparation Scale score's < 2 in at least one of the three broad regions of the colon (i.e. rectum plus left side colon, transverse colon plus left and right flexures, right colon)
- •inability to provide written informed consent
- •severe uncontrolled coagulopathy
- •impaired renal function
- •pregnancy or breast feeding
- •active gastrointestinal bleeding
- •known allergy to fluorescein
- •residence in institutions
Outcomes
Primary Outcomes
Number of participants with IBD
Time Frame: 4 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Helmut Neumann
Professor
University of Erlangen-Nürnberg Medical School
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Identification of Scores Associated With a Favorable Clinical Response With Thiopurines in IBD PatientsInflammatory Bowel DiseasesNCT02367326Centre Hospitalier Universitaire de Saint Etienne400
Unknown
Not Applicable
Biomarker-based Multidisciplinary Team (Bio-MDT) Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's DiseaseInflammatory Bowel DiseasesNCT04082559Rabin Medical Center170
Recruiting
Phase 1
Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel DiseaseUlcerative ColitisCrohn DiseaseNCT06117423University Medical Center Groningen21
Recruiting
Phase 1
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel DiseaseUlcerative Colitis (UC)Crohn Disease (CD)NCT06606808University Medical Center Groningen18
Recruiting
Not Applicable
Remote Monitoring of IBDInflammatory Bowel DiseasesUlcerative ColitisCrohn DiseaseNCT05886322Maastricht University Medical Center400