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

NCT05921643 | Recruiting

• 1 other identifier: GLASS-BONA
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholesteatoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Device: verre bioactif 45S5 GlassBONE; Device: verre bioactif S53P4 Bonalive

Interventions

verre bioactif 45S5 GlassBONE DEVICE

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.

patient with cholesteatoma who has never been operated on

verre bioactif S53P4 Bonalive DEVICE

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.

patient with cholesteatoma who has never been operated on

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

Hôpital Lyon Sud

Lyon, Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Conditions

Cholesteatoma

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Maxime fieux

CONTACT

04.72.66.64.15; maxime.fieux@chu-lyon.fr

Camille JUNG

CONTACT

01 57 02 20 30; camille.jung@chicreteil.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: September 29, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)