Actively Recruiting
Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass"
Led by Centre Hospitalier Intercommunal Creteil · Updated on 2025-06-12
70
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Adult patients referred to the ENT surgery department of the Hospices Civils de Lyon with cholesteatoma that had never been operated on. All patients will benefit from surgical management for cholesteatoma initially in the operating room under general anesthesia. The surgical technique (closed technique) is the reference technique for the management of cholesteatoma in adults. It involves a cartilaginous removal to reconstruct the attical region. Then a filling material is used to fill the mastoid (GlassBONE™ or Bonalive™), and above all to stabilize the cartilaginous fragment to prevent a recurrence.
CONDITIONS
Official Title
Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients at least 18 years old
- Patients with proven cholesteatoma
- Patients who require and agree to surgery using the closed technique with filling of the mastoid or tympanic epitympanum
- Patients undergoing first-time surgery with mastoid filling
You will not qualify if you...
- Known malformations of the outer, middle, or inner ear
- Congenital cholesteatoma
- Previously operated cholesteatoma
- Cholesteatoma requiring open surgical technique or associated with chronic non-cholesteatomatous otitis
- Contraindications to the use of GlassBONE™ or Bonalive™
- Pregnant, parturient, or nursing mothers
- Persons deprived of liberty by judicial or administrative decision, under psychiatric care, legally protected adults, or unable to express themselves
- Participants in other interventional research that may affect the primary endpoint
- Patients objecting to the use of their data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital Lyon Sud
Lyon, Pierre-Bénite, France, 69495
Actively Recruiting
Research Team
M
Maxime fieux
CONTACT
C
Camille JUNG
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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