Conductive Hearing LossCone-BeamNCT06164184
Interest of the Cone Beam Scanner of Temporal Bones in the Analysis of Conductive Hearing Loss
An observational study of Conductive Hearing Loss, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conductive Hearing Loss
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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.
Who cannot join
- Subject who expressed their opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Radiologie 1 - CHU de Strasbourg - France
Strasbourg, 67091
Francis VEILLON, MD, PhD, 33 3 88 12 78 65, francis.veillon@chru-strasbourg.fr
Francis VEILLON, MD, PhD
About this study
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
- Conditions
- Conductive Hearing Loss
- Keywords
- Conductive Hearing Loss, Cone Beam, Cone beam CT, CBCT, Temporal bones
- Medical subject headings
- Hearing Loss, Conductive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Files analysed retrospectively from January 01, 2018 to December 31, 2020 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Oct 2020
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conductive Hearing LossStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164184
- Sponsor's protocol ID
- 8012
- Acronym
- Cone-Beam
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Cone Beam Scanner of Temporal Bones in the Analysis of Conductive Hearing Loss
- ClinicalTrials.gov ID
- NCT06164184
- Acronym / sponsor ID
- Cone-Beam / 8012
- Conditions
- Conductive Hearing Loss
- Keywords
- Conductive Hearing Loss, Cone Beam, Cone beam CT, CBCT, Temporal bones
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Subject who expressed their opposition to participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Show retrospectively that the superiority of the cone beam over the scanner in the diagnosis of conductive hearing loss
Time frame: Files analysed retrospectively from January 01, 2018 to December 31, 2020 will be examined
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conductive Hearing Loss, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francis VEILLON, MD, PhD (33 3 88 12 78 65, francis.veillon@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Show retrospectively that the superiority of the cone beam over the scanner in the diagnosis of conductive hearing loss (time frame: Files analysed retrospectively from January 01, 2018 to December 31, 2020 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.