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

Cholesteatoma Clinical Trial

— GLASS-BONA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921643
• Other study ID #: GLASS-BONA
• Status: Recruiting
• Start date: September 29, 2023
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Maxime fieux
• Phone: 04.72.66.64.15
• Email: maxime.fieux[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Patients are operated on as an outpatient and receive a phone call the next morning to look for an initial complication. The patients will be reviewed in consultation at D8, D45, 3 months, 6 months and at 18 months with clinical examination (otoscopy) and audiometry at each consultation. The consultation on D8 is used for removal of the expandable cotton put in place in the external auditory canal (CAE) during surgery to guide healing, control post-auricular healing and look for signs of complication during the examination. A cone beam (CBCT) is performed during the consultation on D45 to confirm the correct position of the ossiculoplasty and check the persistence of the initial filling. The proportion of filled mastoid at D45 will serve as a reference to then be compared to the CT scan at 6 months and at 18 months. During surgery, and at the consultation at 6 months and 18 months, patients will also have to complete a quality of life questionnaire (Chronic Ear Survey French version; in the Appendix).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Background:
• Known outer, middle or inner ear malformation
• Congenital cholesteatoma
• Previously operated cholesteatoma
• Cholesteatoma requiring an open technique or presenting with chronic non-cholesteatomatous otitis
• Contraindications to the use of GlassBONE™ or Bonalive™
• Pregnant, parturient or nursing mothers
• Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, adults subject to a measure of legal protection or unable to express themselves
• Patient participating in interventional research excluding routine care research (old regulations) and category 2 research that does not interfere with the analysis of the primary endpoint
• Patient objecting to the use of their data

Related Conditions & MeSH terms

• Cholesteatoma

Intervention

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.
• 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

Country	Name	City	State
France	Hôpital Lyon Sud	Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mastoid filling	A patient will be considered as a responder if the proportion of mastoid filling at 6 months is strictly greater than 70% compared to the reference measurement	6 month