Stapes Footplate Thickness Measured With UHR-CT

April 3, 2023 updated by: GILLET Romain, Central Hospital, Nancy, France
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

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

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients refered to our department between october 2020 and October 2022 for an ultra high resolution CT of the temporal bone

Description

Inclusion Criteria:

  • Ultra high resolution CT of the temporal bone available

Exclusion Criteria:

  • previous surgery

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
otosclerosis
otosclerosis patients
Diagnostic test: ultra-high resolution CT
stapes footplate thickness measurement
chronic otitis media
otitis media with middle ear opacities
Diagnostic test: ultra-high resolution CT
stapes footplate thickness measurement
controls
sudden ear loss, pre-implantatory imaging, vertigo, tympanic perforation
Diagnostic test: ultra-high resolution CT
stapes footplate thickness measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
october 2020-october 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
interobserver variability
Time Frame: october 2020-october 2022
interobserver variability
october 2020-october 2022

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: romain gillet, md, CHRU de NANCY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

April 28, 2023

Primary Completion (Anticipated)

June 28, 2023

Study Completion (Anticipated)

June 28, 2023

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N°3-RCB/EUDRACT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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