CLE for Differential Diagnosis of IBD

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02238665

Enrollment

105

Registered

2014-09-12

Start date

2009-10-31

Completion date

2014-09-30

Last updated

2014-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

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.

Interventions

DEVICEEndomicroscopy

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of participants with IBD	4 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026