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Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis

NCT ID: NCT01234376

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

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-12-31

Brief Summary

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Confocal laser endomicroscopy enables in vivo microscopic imaging within the mucosa layer of the gut at a subcellular resolution. Various studies have addressed the potential of endomicroscopy for the in vivo diagnosis of esophageal squamous cell carcinoma, Barrett´s esophagus and esophageal adenocarcinoma. Currently, there is only one case report from our group who noted the utility of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis.

The purpose of this study is to determine whether endomicroscopy is effective for the in vivo diagnosis of eosinophilic esophagitis.

Detailed Description

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Conditions

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Eosinophilic Esophagitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Control patients

Confocal laser endomicroscopy

Intervention Type DEVICE

Confocal laser endomicroscopy

Patients with eosinophilic esophagitis

Confocal laser endomicroscopy

Intervention Type DEVICE

Confocal laser endomicroscopy

Interventions

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Confocal laser endomicroscopy

Confocal laser endomicroscopy

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 EGD

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Markus F. Neurath, M.D., Ph.D.

Role: STUDY_DIRECTOR

University of Erlangen-Nürnberg

Helmut Neumann, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Erlangen-Nürnberg

Locations

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University of Erlangen-Nuremberg

Erlangen, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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HN-0003

Identifier Type: -

Identifier Source: org_study_id