Clinical and Radiological Evaluation of Two Mastoid Filling Products

Prospective Study Clinical Trial

— MASTOS  

Official title:

Clinical and Radiological Evaluation of Two Mastoid Filling Products in Patients With Cholesteratoma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05072678
• Other study ID #: 29BRC21.0018 (MASTOS)
• Status: Recruiting
• Start date: April 25, 2021
• Est. completion date: April 25, 2023

Study information

• Verified date: April 2021
• Source: University Hospital, Brest
• Contact: remi Marianowski, MD, PhD
• Phone: 33298223333
• Email: remi.marianowski[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

to compare, the osseous density in the mastoid of two products used to obliterate the mastoid during surgery for cholesteatoma

Description:

Primary objective: To compare the radiological aspect in the petrous bone of two obliteration products in adults, one year after surgery (Bioactive Glass S53P4 and biological Hydroxy apatite) secondary objective : To evaluate the cutaneous and the inner ear tolerance of bioactive glass S53P4 and biological hydroxy apatite when used in the mastoid and epitympanic obliteration for chronic otitis surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 25, 2023
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult with cholesteatoma surgery Accepting the protocol and the radiological follow-up

Exclusion Criteria:

• patient less than 18 years old

Related Conditions & MeSH terms

• Prospective Study

Locations

Country	Name	City	State
France	CHRU De Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hounsfield Unit	The attenuation and osseointegration of the BG granules: The quantitative analysis included bone attenuation measurements (in Hounsfield units, HU) in the circular region of interest (34mm2) of BGand of surrounding cortical bone and otic capsule using the otic capsule adjacent to the LSCC and the posterior fossa dural plate (DP)	one year
Secondary	decibel	Auditory level pre and postoperative evaluation clinical	one year
Secondary	decibel	audiological evaluation	one year