Interest of the Cone Beam Scanner of Temporal Bones in th... | NCT06164184

Studies
Interest of the Cone Beam Scanner of Temporal Bones in the Analysis of Conductive Hearing Loss

NCT06164184

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Dec 11, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Conductive Hearing Loss

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

Oct 1, 2020Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Nov 29, 2022

First Submission Date that Met QC Criteria

Dec 7, 2023

First Posted Date

Dec 11, 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 7, 2023

Last Update Posted Date

Dec 11, 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

Conductive hearing loss is very common and the incidence increases with age. Until now, the scanner was the reference examination in the etiological diagnosis of deafness.

When performing a CT scan of temporal bones for the etiological diagnosis of conductive hearing loss, the quality of the image depends on the scanner brand and the acquisition parameters.

The investigators wish to show the usefulness of the cone beam in the diagnosis of conductive hearing loss

Detailed Description

Not provided

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Show retrospectively that the superiority of the cone beam over the scanner in the diagnosis of conductive hearing loss	This superiority is based on the quality of the images allowing the visualization of the different elements of the middle and inner ears: Ossicles, windows, nerves (VII and VIII), cochlea, labyrinth	Files analysed retrospectively from January 01, 2018 to December 31, 2020 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Major subject (≥18 years old)
Subject having performed a CT scan or a cone beam for pre- and post-operative conductive hearing loss between January 01, 2018 and December 31, 2020
Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

Subject who expressed their opposition to participating in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Major subject (≥18 years old) having performed a CT scan or a cone beam for pre- and post-operative conductive hearing loss between January 01, 2018 and December 31, 2020

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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Radiologie 1 - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D006314	Hearing Loss, Conductive

Ancestor Terms

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided