KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING | NCT06179251

Studies
KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING

NCT06179251

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Dec 21, 2023Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Otosclerosis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 13, 2021Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Dec 11, 2023

First Submission Date that Met QC Criteria

Dec 11, 2023

First Posted Date

Dec 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2023

Last Update Posted Date

Dec 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Measure	Description	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		up to 10 month

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
francis VEILLON, MD, PhD	Contact	33 3 88 12 78 65		francis.veillon@chru-strasbourg.fr
Floriane LE NORMAND, MD	Contact	33 3 88 12 78 65		floriane.le-normand@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Radiologie - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

ID	Term
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases