Endomicroscopy for Assessment of Mucosal Healing

NCT ID: NCT01417715

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-08-31

Brief Summary

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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

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Conditions

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Crohn´s Disease Ulcerative Colitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Crohn´s disease - active

Patients with Crohn´s disease in the active phase.

Endomicroscopy

Intervention Type DEVICE

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.

Endomicroscopy

Intervention Type DEVICE

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.

Endomicroscopy

Intervention Type DEVICE

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.

Endomicroscopy

Intervention Type DEVICE

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

Interventions

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Endomicroscopy

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helmut Neumann, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine I, University of Erlangen-Nuremberg, Germany

Markus F. Neurath, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine I, University of Erlangen-Nuremberg, Germany

Locations

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University of Erlangen-Nuremberg

Erlangen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HN-0008

Identifier Type: -

Identifier Source: org_study_id