The Safety of S53P4 Bioactive Glass for Mastoid Obliteration

CompletedOBSERVATIONAL
Enrollment

1,196

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

September 1, 2024

Study Completion Date

March 1, 2025

Conditions
Mastoid Cavity
Interventions
DEVICE

S53P4 Bioactive glass

Following mastoidectomy, the mastoid cavity, and if the ossicular chain has been removed the epitympanum as well, are obliterated using S53P4 bioactive glass. The bioactive glass is mixed with saline and administered to the cavity, ensuring a tight fit.

Trial Locations (1)

3582KE

Diakonessenhuis, Utrecht

All Listed Sponsors
lead

Diakonessenhuis, Utrecht

OTHER