Short- and Medium-term Evaluation of Mastoid Filling Using Bioactive Glass

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients at least 18 years old

• Patients with proven cholesteatoma

• Patient requiring and agreeing to surgery with filling of the mastoid or tympanic epi (closed technique with filling)

• Patient having a surgery with filling in first intention

Locations
Other Locations
France
Hôpital Lyon Sud
RECRUITING
Lyon
Contact Information
Primary
Maxime fieux
maxime.fieux@chu-lyon.fr
04.72.66.64.15
Backup
Camille JUNG
camille.jung@chicreteil.fr
01 57 02 20 30
Time Frame
Start Date: 2023-09-29
Estimated Completion Date: 2027-04
Participants
Target number of participants: 70
Treatments
patient with cholesteatoma who has never been operated on
All patients will benefit from surgical management for a first stage cholesteatoma 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. The mastoid filler used is left to the discretion and habits of the surgeon.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Intercommunal Creteil

This content was sourced from clinicaltrials.gov