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RECRUITING
NCT05921643

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

Sponsor: Centre Hospitalier Intercommunal Creteil

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2023-09-29

Completion Date

2027-04

Last Updated

2025-06-12

Healthy Volunteers

No

Conditions

Interventions

DEVICE

verre bioactif 45S5 GlassBONE

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.

DEVICE

verre bioactif S53P4 Bonalive

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.

Locations (1)

Hôpital Lyon Sud

Lyon, Pierre-Bénite, France