- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03915392
Diffusion Weighted MRI Accuracy in Cholesteatoma Localization (CHOLEMRI)
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Antoine MERANGER, MD
- Phone Number: 33 3 88 12 76 49
- Email: antoine.meranger@chru-strasbourg.fr
Study Locations
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Strasbourg, France, 67091
- Recruiting
- Service D'Orl Et de Chirurgie Cervico-Faciale
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Contact:
- Antoine MERANGER, MD
- Phone Number: 33 3 88 12 76 49
- Email: antoine.meranger@chru-strasbourg.fr
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Sub-Investigator:
- Antoine MERANGER, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
inclusion criteria
- Age: from 1 month and up
- Sex: man / woman
Patient who had a tympanoplasty in closed technique, for the first surgical time of a cholesteatoma or for residual or recurrent cholesteatoma, performed by the same radiologist (Pr Anne Charpiot) with the following characteristics:
Code of the Common Classification of Medical Acts (CCAM)
- Exeresis of cholesteatoma with tympanoplasty in closed technique and ossiculoplasty (CBFA002)
- Exeresis of cholesteatoma with tympanoplasty in closed technique (CBFA006)
- Exeresis of cholesteatoma confined to the tympanic cavity without antro-attic exploration (CBFA005)
- Tympanoplasty in closed technique with posterior tympanotomy (CBMD001)
- Secondary tympanoplasty in closed technique (CBMD002)
Diagnostic code of the International Classification of Diseases (ICD10)
- Cholesteatoma of the middle ear (H71)
- Diagnosis of macroscopic and / or pathological cholesteatoma.
- Preoperative diagnosis of cholesteatoma on MRI of the middle ear performed in less than 6 months by the same radiologist (Pr Francis Veillon).
- Subject (or the holders of parental authority in the case of minors) having agreed to the use of medical data for the purpose of this research.
Cholesteatoma is a very common disease in the pediatric population, with important functional issues, whose treatment is surgical. That's why our study includes minor subjects.
Criteria of non-inclusion
- Refusal of the patient to participate in the study
- Absence of data concerning the diagnosis and / or localization of cholesteatoma on the operative record
- Subject under the protection of justice
- Subject under guardianship or curatorship
- Pregnancy (woman of childbearing age)
- Breastfeeding
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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MRI imaging study to locate cholesteatoma.
Time Frame: The period from January 1st, 2010 to Dcember 31, 2017 will be examined
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The period from January 1st, 2010 to Dcember 31, 2017 will be examined
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Collaborators and Investigators
Investigators
- Study Director: Anne CHARPIOT, MD, PhD, University Hospital, Strasbourg, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7122
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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