Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT03915392
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03915392
Study Brief:
Protocol Section:
NCT03915392