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Endomicroscopy and Crohn´s Disease

This study has been completed.
Information provided by:
University of Erlangen-Nürnberg Medical School Identifier:
First received: April 12, 2010
Last updated: August 10, 2011
Last verified: August 2011


The main objective of this study is to determine endomicroscopic features of Crohn´s disease.


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.


In patients with Crohn´s disease.

Crohn´s Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Confocal Laser Endomicroscopy in Patients With Crohn´s Disease

Resource links provided by NLM:

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • To determine endomicroscopic features of Crohn´s disease. [ Time Frame: October 2009 until May 2010 ]

Secondary Outcome Measures:
  • Comparison of CLE findings with conventional histology. [ Time Frame: October 2009 until May 2010 ]

Estimated Enrollment: 40
Study Start Date: October 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Detailed Description:


Patients underwent colonoscopy for the evaluation of Crohn´s disease. During the endoscopic procedure CLE will be performed.


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.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Crohn´s disease.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01102855

Department of Medicine I, University of Erlangen-Nuremberg
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Study Director: Markus F. Neurath University of Erlangen-Nürnberg
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Markus F. Neurath, M.D., Ph.D., University of Erlangen-Nuremberg Identifier: NCT01102855     History of Changes
Other Study ID Numbers: HN-0002
Study First Received: April 12, 2010
Last Updated: August 10, 2011

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on August 21, 2017