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Endomicroscopy for Assessment of Mucosal Healing

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ClinicalTrials.gov Identifier: NCT01417715
Recruitment Status : Unknown
Verified January 2013 by Helmut Neumann, University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Recruiting
First Posted : August 16, 2011
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns 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.

The main objective of this study is to determine endomicroscopic features of mucosal healing in patients with IBD.


Condition or disease Intervention/treatment
Crohn´s Disease Ulcerative Colitis Device: Endomicroscopy

Study Design

Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Advanced Endoscopic Imaging Using Endomicroscopy for Assessment of Mucosal Healing in IBD
Study Start Date : August 2011
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Crohn´s disease - active
Patients with Crohn´s disease in the active phase.
Device: Endomicroscopy
Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.
Crohn´s disease - quiescent
Patients with Crohn´s disease in the quiescent phase.
Device: Endomicroscopy
Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.
Ulcerative colitis - active
Patients with ulcerative colitis in the active stage.
Device: Endomicroscopy
Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.
Ucerative colitis - quiescent
Patients with ulcerative colitis in the quiescent stage.
Device: Endomicroscopy
Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.


Outcome Measures

Primary Outcome Measures :
  1. Mucosal healing [ Time Frame: up to three years ]
    We will determine endomicroscopic features of mucosal inflammation (e.g. goblet cell depletion, leackage, microvessel density) in IBD in order to establish a new endoscopic classification of mucosal healing.


Secondary Outcome Measures :
  1. Histologic correlation [ Time Frame: up to three years ]
    Comparison of clinical and histopathological data with endoscopic findings to evaluate mucosal healing as a parameter of remission and relapse in patients with IBD.

  2. Therapeutic effect [ Time Frame: up to three years ]
    We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment) on characteristics of mucosal healing (e.g. goblet cell depletion, microvessels, leakage).


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Crohn´s disease and ulcerative colitis in the active and quiescent phase of the disease.
Criteria

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)
  • Pregnancy or breast feeding
  • Active gastrointestinal bleeding
  • Residing in institutions (e.g. prison)
  • Known allergy against fluorescein
  • Proctocolectomy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417715


Contacts
Contact: Helmut Neumann, Professor +4991318535000 helmut.neumann@uk-erlangen.de
Contact: Markus F. Neurath, Professor +4991318535000 markus.neurath@uk-erlangen.de

Locations
Germany
University of Erlangen-Nuremberg Recruiting
Erlangen, Germany, 91054
Contact: Helmut Neumann, Professor    +4991318535000    helmut.neumann@uk-erlangen.de   
Principal Investigator: Helmut Neumann, Professor         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Helmut Neumann, Professor Department of Medicine I, University of Erlangen-Nuremberg, Germany
Principal Investigator: Markus F. Neurath, Professor Department of Medicine I, University of Erlangen-Nuremberg, Germany
More Information

Responsible Party: Helmut Neumann, Professor, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01417715     History of Changes
Other Study ID Numbers: HN-0008
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases