Endomicroscopy for Assessment of Mucosal Healing

This study is currently recruiting participants.

Verified January 2013 by University of Erlangen-Nürnberg Medical School

Sponsor:

Information provided by (Responsible Party):

Helmut Neumann, University of Erlangen-Nürnberg Medical School

ClinicalTrials.gov Identifier:

NCT01417715

First received: August 10, 2011

Last updated: January 23, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 10, 2011

Last Updated Date

January 23, 2013

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mucosal healing [ Time Frame: up to three years ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01417715 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Histologic correlation [ Time Frame: up to three years ] [ Designated as safety issue: Yes ]
Comparison of clinical and histopathological data with endoscopic findings to evaluate mucosal healing as a parameter of remission and relapse in patients with IBD.
Therapeutic effect [ Time Frame: up to three years ] [ Designated as safety issue: Yes ]
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).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Endomicroscopy for Assessment of Mucosal Healing

Official Title ^ICMJE

Advanced Endoscopic Imaging Using Endomicroscopy for Assessment of Mucosal Healing in IBD

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with Crohn´s disease and ulcerative colitis in the active and quiescent phase of the disease.

Condition ^ICMJE

Crohn´s Disease
Ulcerative Colitis

Intervention ^ICMJE

Device: Endomicroscopy

Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.

Study Group/Cohort (s)

Crohn´s disease - active
Patients with Crohn´s disease in the active phase.

Intervention: Device: Endomicroscopy
Crohn´s disease - quiescent
Patients with Crohn´s disease in the quiescent phase.

Intervention: Device: Endomicroscopy
Ulcerative colitis - active
Patients with ulcerative colitis in the active stage.

Intervention: Device: Endomicroscopy
Ucerative colitis - quiescent
Patients with ulcerative colitis in the quiescent stage.

Intervention: Device: Endomicroscopy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2014

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01417715

Other Study ID Numbers ^ICMJE

HN-0008

Has Data Monitoring Committee

Yes

Responsible Party

Helmut Neumann, University of Erlangen-Nürnberg Medical School

Study Sponsor ^ICMJE

University of Erlangen-Nürnberg Medical School

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University of Erlangen-Nürnberg Medical School

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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