Clinical and Radiological Evaluation of Two Mastoid Filling Products

NCT ID: NCT05072678

Last Updated: 2021-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-25

Study Completion Date

2023-04-25

Brief Summary

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

Detailed Description

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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

Conditions

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Prospective Study

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patient less than 18 years old
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU De Brest

Brest, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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remi Marianowski, MD, PhD

Role: CONTACT

33298223333 ext. CHU Brest

sonia Sahli Vivi Corsi, MD

Role: CONTACT

33298223052

Facility Contacts

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Remi Marianowski, MD,PhD

Role: primary

33298223333

Other Identifiers

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29BRC21.0018 (MASTOS)

Identifier Type: -

Identifier Source: org_study_id

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