CLE for Differential Diagnosis of IBD

Inflammatory Bowel Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238665
• Other study ID #: HN-0005
• Status: Completed
• Phase: N/A
• First received: September 9, 2014
• Last updated: September 11, 2014
• Start date: October 2009
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics committee University Hospital Erlangen
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: September 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Intervention

Device:
• Endomicroscopy

Locations

Country	Name	City	State
Germany	University Hospital Erlangen	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with IBD		4 years	No