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NCT05799404 Clinical Trial

Stapes Footplate Thickness Measured With UHR-CT

Otitis Media Clinical Trial

Official title:
Stapes Footplate Thickness Measured With UHR-CT

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05799404
Other study ID # N°3-RCB/EUDRACT
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 28, 2023
Est. completion date June 28, 2023

Study information
Verified date April 2023
Source Central Hospital, Nancy, France
Contact romain gillet, MD
Phone 003383851811
Email r.gillet@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date June 28, 2023
Est. primary completion date June 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ultra high resolution CT of the temporal bone available Exclusion Criteria: - previous surgery

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• ultra-high resolution CT
stapes footplate thickness measurement

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

References & Publications (2)

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. — View Citation

Tang 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 october 2020-october 2022
Secondary interobserver variability interobserver variability october 2020-october 2022
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