Endomicroscopy and Crohn´s Disease
Confocal Laser Endomicroscopy in Patients With Crohn´s Disease
1 other identifier
observational
40
1 country
1
Brief Summary
Purpose: The main objective of this study is to determine endomicroscopic features of Crohn´s disease. Background: Crohn´s disease is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. Diagnosis is based on several histologic features including transmural pattern of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure. Scope: In patients with Crohn´s disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 12, 2010
CompletedFirst Posted
Study publicly available on registry
April 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedAugust 11, 2011
August 1, 2011
1.8 years
April 12, 2010
August 10, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To determine endomicroscopic features of Crohn´s disease.
October 2009 until May 2010
Secondary Outcomes (1)
Comparison of CLE findings with conventional histology.
October 2009 until May 2010
Eligibility Criteria
Patients with Crohn´s disease.
You may qualify if:
- Written informed consent
- Age 18-85 years
- Ability of subjects to understand character and individual consequences of clinical trial
- Subjects undergoing colonoscopy
You may not qualify if:
- Inability to provide written informed consent
- Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
- Impaired renal function (Creatinine \> 1.2 mg/dl)
- Pregnancy or breast feeding
- Active gastrointestinal bleeding
- Known allergy to fluorescein, acriflavin or cresyl violet
- Residing in institutions (e.g. prison)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine I, University of Erlangen-Nuremberg
Erlangen, 91054, Germany
Related Publications (1)
Neumann H, Vieth M, Atreya R, Grauer M, Siebler J, Bernatik T, Neurath MF, Mudter J. Assessment of Crohn's disease activity by confocal laser endomicroscopy. Inflamm Bowel Dis. 2012 Dec;18(12):2261-9. doi: 10.1002/ibd.22907. Epub 2012 Feb 16.
PMID: 22344873DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Markus F. Neurath
University of Erlangen-Nürnberg
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 12, 2010
First Posted
April 13, 2010
Study Start
October 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
August 11, 2011
Record last verified: 2011-08