NCT06164184

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

3.2 years

First QC Date

November 29, 2022

Last Update Submit

December 7, 2023

Conditions

Keywords

Conductive Hearing LossCone BeamCone beam CTCBCTTemporal bones

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • Subject who expressed their opposition to participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Radiologie 1 - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 11, 2023

Study Start

October 1, 2020

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations