Clinical and Radiological Evaluation of Two Mastoid Filling Products (MASTOS)

September 28, 2021 updated by: University Hospital, Brest

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

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

Study Overview

Status

Recruiting

Conditions

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with cholesteatoma surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • patient less than 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hounsfield Unit
Time Frame: one year

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
decibel
Time Frame: one year
Auditory level pre and postoperative evaluation clinical
one year
decibel
Time Frame: one year
audiological evaluation
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2021

Primary Completion (Anticipated)

April 25, 2022

Study Completion (Anticipated)

April 25, 2023

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

September 28, 2021

First Posted (Actual)

October 11, 2021

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 29BRC21.0018 (MASTOS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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