KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING (Luxation)

December 11, 2023 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

40

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

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Radiologie - CHU de Strasbourg - France
        • Principal Investigator:
          • Francis VEILLON, MD, PhD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Floriane LE NORMAND, MD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults (≥18 years old) and minors (≥ 6 years old) 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

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence or absence of the anatomical structure referenced in the investigators' reading grid on each of the 6 predefined MRI or CT sections
Time Frame: up to 10 month
up to 10 month

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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 (Actual)

December 13, 2021

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Estimated)

December 21, 2023

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8488

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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