Prospective StudyMASTOSNCT05072678
Clinical and Radiological Evaluation of Two Mastoid Filling Products
An observational study of Prospective Study, run by University Hospital, Brest at 1 site in France.
Trial summary
to compare, the osseous density in the mastoid of two products used to obliterate the mastoid during surgery for cholesteatoma Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prospective Study
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2021to 25 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with cholesteatoma surgery
Who may be able to join
- Adult with cholesteatoma surgery Accepting the protocol and the radiological follow-up
Who cannot join
- patient less than 18 years old
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU De Brest
Brest, 29200
Remi Marianowski, MD,PhD, 33298223333, remi.marianowski@chu-brest.fr
About this study
Official title: 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
Read the 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
- Conditions
- Prospective Study
- Keywords
- osteoingration, surgery, cholesteatome
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one year
Secondary outcomes (2)
decibel
Auditory level pre and postoperative evaluation clinical
Measured: one year
decibel
audiological evaluation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start25 Apr 2021
- Primary completion25 Apr 2022 (estimated)
- Study completion25 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prospective StudyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072678
- Sponsor's protocol ID
- 29BRC21.0018 (MASTOS)
- Acronym
- MASTOS
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Evaluation of Two Mastoid Filling Products in Patients With Cholesteratoma.
- ClinicalTrials.gov ID
- NCT05072678
- Acronym / sponsor ID
- MASTOS / 29BRC21.0018 (MASTOS)
- Conditions
- Prospective Study
- Keywords
- osteoingration, surgery, cholesteatome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 25 Apr 2022 (estimated)
- Study completion
- 25 Apr 2023 (estimated)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to compare, the osseous density in the mastoid of two products used to obliterate the mastoid during surgery for cholesteatoma
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with cholesteatoma surgery
Key inclusion criteria (1 listed)
- Adult with cholesteatoma surgery Accepting the protocol and the radiological follow-up
Key exclusion criteria (1 listed)
- patient less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
decibel
Time frame: one year
decibel
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prospective Study, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact remi Marianowski, MD, PhD (33298223333 ext. CHU Brest, remi.marianowski@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hounsfield Unit (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.