- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01102855
Endomicroscopy and Crohn´s Disease
Confocal Laser Endomicroscopy in Patients With Crohn´s Disease
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.
Study Overview
Status
Conditions
Detailed Description
Methods:
Patients underwent colonoscopy for the evaluation of Crohn´s disease. During the endoscopic procedure CLE will be performed.
Procedure:
The patient underwent colonoscopy. During the procedure the patient will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Erlangen, Germany, 91054
- Department of Medicine I, University of Erlangen-Nuremberg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Written informed consent
- Age 18-85 years
- Ability of subjects to understand character and individual consequences of clinical trial
- Subjects undergoing colonoscopy
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine endomicroscopic features of Crohn´s disease.
Time Frame: October 2009 until May 2010
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October 2009 until May 2010
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of CLE findings with conventional histology.
Time Frame: October 2009 until May 2010
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October 2009 until May 2010
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Collaborators and Investigators
Investigators
- Study Director: Markus F. Neurath, University of Erlangen-Nürnberg
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HN-0002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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