KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING

Otosclerosis Clinical Trial

— Luxation  

Official title:

KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING: INTEREST IN INTRAVESTIBULAR DISLOCATIONS OF PISTONS OR CALIPER

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179251
• Other study ID #: 8488
• Status: Recruiting
• Start date: December 13, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: francis VEILLON, MD, PhD
• Phone: 33 3 88 12 78 65
• Email: francis.veillon[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Titanium pistons cause MRI artifacts that prevent interpretation of the vestibule. This disadvantage is not present on CT but the vestibule is not visible. Hence the interest in creating a model with 6 reference cuts in order to position the utricle and the saccule in the vestibule in CT. Furthermore, the scanner has fewer contraindications, greater availability and a shorter examination time than MRI.

Description:

The aim of the study is to analyze six normal sections chosen as reference in histology, high resolution T2 MRI and CT in order to compare them with precise topographical landmarks to position the posterior membranous labyrinth in CT. Then, apply the investigators' observations to cases of operated otosclerosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Adults (=18 years old) and minors (= 6 years old)
• Subject having received an MRI of the internal ear canals from the HUS between 01/01/2018 and 01/01/2021 or a CT scan of the rocks between 07/01/2015 and 01/01/2021
• Normal MRI or CT on the side opposite the pathology.
• Normal tonal audiogram on the side opposite the pathology (peripheral facial paralysis assumed to be cold for MRI and petrous fracture for CT).
• Subject who has not expressed his opposition, after information, to the reuse of his data for the purposes of this research.
• Holders of authority who have not expressed their opposition, after information, to the reuse of their child's data for the purposes of this research

Exclusion Criteria:

• Subject having expressed opposition to participating in the study
• Holders of parental authority who have expressed their opposition to the reuse of their child's data for the purposes of this research
• Imaging with artifacts
• Absence of pure-tone audiogram or its abnormality on the side of the ear studied
• Any malformation or pathology of the vestibule on imaging on the side of the ear studied
• Subjects under guardianship or curatorship

Related Conditions & MeSH terms

• Otosclerosis

Locations

Country	Name	City	State
France	Service de Radiologie - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of the anatomical structure referenced in the investigators' reading grid on each of the 6 predefined MRI or CT sections		up to 10 month