OtosclerosisLuxationNCT06179251
KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING
An observational study of Otosclerosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Otosclerosis
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2021to 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Radiologie - CHU de Strasbourg - France
Strasbourg, 67091
Francis VEILLION, MD, PhD, 33 3 88 12 78 65, francis.veillon@chru-strasbourg.fr
Floriane LE NORMAND, MD, 33 3 88 12 78 65, floriane.le-normand@chru-strasbourg.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Otosclerosis
- Keywords
- Otosclerosis, Vestibular dysfunction, Membranous Labyrinth
- Medical subject headings
- Otosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of the anatomical structure referenced in the investigators' reading grid on each of the 6 predefined MRI or CT sections
Measured: up to 10 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start13 Dec 2021
- 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 OtosclerosisStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 40 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
- NCT06179251
- Sponsor's protocol ID
- 8488
- Acronym
- Luxation
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 21 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 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING: INTEREST IN INTRAVESTIBULAR DISLOCATIONS OF PISTONS OR CALIPER
- ClinicalTrials.gov ID
- NCT06179251
- Acronym / sponsor ID
- Luxation / 8488
- Conditions
- Otosclerosis
- Keywords
- Otosclerosis, Vestibular dysfunction, Membranous Labyrinth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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 Otosclerosis, 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 6 inclusion and 6 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 21 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?
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). 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 21 Dec 2023.