OtosclerosisNCT05799404
Stapes Footplate Thickness Measured With UHR-CT
An observational study of Otosclerosis and Otitis Media, run by Central Hospital, Nancy, France.
Trial summary
The aim of this study is to compare the thickness of the stapes footplate measured with ultra high resolution CT in control patients, otosclerosis patients and chronic otitis media patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otosclerosis, Otitis Media
- What is being tested?
- ultra-high resolution CT
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2023to 28 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients refered to our department between october 2020 and October 2022 for an ultra high resolution CT of the temporal bone
Who may be able to join
- Ultra high resolution CT of the temporal bone available
Who cannot join
- previous surgery
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to compare the thickness of the stapes footplate measured with ultra high resolution CT in control patients, otosclerosis patients and chronic otitis media patients.
Read the detailed description
Stapes footplate thickness will be measured under its anterior crus, its posterior crus and at its midpoint, in both the stapes axial plane and the laletral semi-circular canal planes.
- Conditions
- Otosclerosis, Otitis Media
- Being tested
- ultra-high resolution CT
- Keywords
- ultra high resolution, ct, stapes, footplate, otosclerosis, otitis media
- Medical subject headings
- Otosclerosis, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra-high resolution CTDiagnostic test
stapes footplate thickness measurement
| Study group | Role | What they receive |
|---|---|---|
| otosclerosis | otosclerosis patients Receives: Diagnostic Test: ultra-high resolution CT | |
| chronic otitis media | otitis media with middle ear opacities Receives: Diagnostic Test: ultra-high resolution CT | |
| controls | sudden ear loss, pre-implantatory imaging, vertigo, tympanic perforation Receives: Diagnostic Test: ultra-high resolution CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
stapes footplate thickness in mm in the stapes axial plane
stapes footplate thickness measured with a digital caliper on our PACS system with the accuracy of a tenth of a millimetre, under the anterior crus of the stapes, under the posterior crus of the stapes, and at its midpoint, in the stapes axial plane and in the lateral semi circular canal plane, to compare both values and find out wich one is the most pertinent
Measured: october 2020-october 2022
Secondary outcomes (1)
interobserver variability
interobserver variability
Measured: october 2020-october 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start28 Apr 2023 (estimated)
- Primary completion28 Jun 2023 (estimated)
- Study completion28 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GILLET Romain, Central Hospital, Nancy, France
- Investigators
- romain gillet, MD, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799404
- Sponsor's protocol ID
- N°3-RCB/EUDRACT
- Status last verified
- Apr 2023
- First submitted
- 5 Dec 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akazawa Y, Ganaha A, Higa T, Kondo S, Oyakawa Y, Hirakawa H, Suzuki M, Yamashiro T. Measurement of stapes footplate thickness in otosclerosis by ultra-high-resolution computed tomography. Acta Otolaryngol. 2020 Nov;140(11):899-903. doi: 10.1080/00016489.2020.1788225. Epub 2020 Jul 23.
PubMed 32700991Tang R, Yin H, Wang Z, Zhang Z, Zhao L, Zhang P, Li J, Zhao P, Lv H, Zhang L, Yang Z, Wang Z. Stapes visualization by ultra-high resolution CT in cadaveric heads: A preliminary study. Eur J Radiol. 2021 Aug;141:109786. doi: 10.1016/j.ejrad.2021.109786. Epub 2021 May 21.
PubMed 34058698
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stapes Footplate Thickness Measured With UHR-CT
- ClinicalTrials.gov ID
- NCT05799404
- Acronym / sponsor ID
- N°3-RCB/EUDRACT
- Conditions
- Otosclerosis, Otitis Media
- Keywords
- ultra high resolution, ct, stapes, footplate, otosclerosis, otitis media
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 28 Apr 2023 (estimated)
- Primary completion
- 28 Jun 2023 (estimated)
- Study completion
- 28 Jun 2023 (estimated)
- First posted
- 5 Apr 2023 (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.
The aim of this study is to compare the thickness of the stapes footplate measured with ultra high resolution CT in control patients, otosclerosis patients and chronic otitis media patients.
Detailed description
Stapes footplate thickness will be measured under its anterior crus, its posterior crus and at its midpoint, in both the stapes axial plane and the laletral semi-circular canal planes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| otosclerosis | – | Diagnostic Test: ultra-high resolution CTotosclerosis patients |
| chronic otitis media | – | Diagnostic Test: ultra-high resolution CTotitis media with middle ear opacities |
| controls | – | Diagnostic Test: ultra-high resolution CTsudden ear loss, pre-implantatory imaging, vertigo, tympanic perforation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients refered to our department between october 2020 and October 2022 for an ultra high resolution CT of the temporal bone
Key inclusion criteria (1 listed)
- Ultra high resolution CT of the temporal bone available
Key exclusion criteria (1 listed)
- previous surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultra-high resolution CTstapes footplate thickness measurement | Diagnostic test | chronic otitis media, controls, otosclerosis |
Primary outcome
stapes footplate thickness in mm in the stapes axial plane
Time frame: october 2020-october 2022
stapes footplate thickness measured with a digital caliper on our PACS system with the accuracy of a tenth of a millimetre, under the anterior crus of the stapes, under the posterior crus of the stapes, and at its midpoint, in the stapes axial plane and in the lateral semi circular canal plane, to compare both values and find out wich one is the most pertinent
1 secondary outcome
interobserver variability
Time frame: october 2020-october 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Background: PubMed 32700991Akazawa Y, Ganaha A, Higa T, Kondo S, Oyakawa Y, Hirakawa H, Suzuki M, Yamashiro T. Measurement of stapes footplate thickness in otosclerosis by ultra-high-resolution computed tomography. Acta Otolaryngol. 2020 Nov;140(11):899-903. doi: 10.1080/00016489.2020.1788225. Epub 2020 Jul 23.
- Background: PubMed 34058698Tang R, Yin H, Wang Z, Zhang Z, Zhao L, Zhang P, Li J, Zhao P, Lv H, Zhang L, Yang Z, Wang Z. Stapes visualization by ultra-high resolution CT in cadaveric heads: A preliminary study. Eur J Radiol. 2021 Aug;141:109786. doi: 10.1016/j.ejrad.2021.109786. Epub 2021 May 21.
- Individual participant dataSharing planned: No
Related trials for Otosclerosis
Active, not recruiting
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Otosclerosis, Cone Beam Computed Tomography
Not yet recruiting
Surgical and Audiological Outcomes of Endoscopic Stapes Surgery
Otosclerosis
RecruitingObservational study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Otosclerosis of Middle Ear, Bone Density
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.
romain gillet, MD principal investigator
CHRU de Nancy
Questions about this trial
What is this clinical trial studying?
An observational study of Otosclerosis and Otitis Media, run by Central Hospital, Nancy, 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 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 romain gillet, MD (003383851811, r.gillet@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stapes footplate thickness in mm in the stapes axial plane (time frame: october 2020-october 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05799404, which also lists 2 linked publications.
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 5 Apr 2023.