Endolymphatic HydropsMRI MeniereNCT03215420
Comparison of 3 Methods to Diagnose Endolymphatic Hydrops in Meniere's Disease
A study testing MRI 3T in people with Endolymphatic Hydrops, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The aim of this study is to compare 3 methods for the diagnosis of endolymphatic hydrops (EH) in patients with Meniere's disease: MRI 3 Tesla (to visualise EH directly), and functional explorations, namely electrocochleography and dephasing of acoustic distortion products (which are modified by the EH). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Endolymphatic Hydrops
- What is being tested?
- MRI 3T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2016to 3 Oct 2018
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persons who have provided written consent
- persons aged 18 to 75 years
- persons with certain, probable or possible Meniere's disease according to the international classification AAO-HNS
Who cannot join
- persons without health insurance cover
- adults under guardianship
- persons with a history of hypersensitivity to the active substance or to one of the excipients of the contrast agent used for the MRI or to any gadolinium chelate
- pregnant or breast-feeding women
- severe acute or chronic kidney failure
- other identified causes of cochleo-vestibular syndromes
- Impossibility to follow-up or carry out any of the examinations necessary for the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Agreement of Electrophysiological Audiovestibular Examinations With Magnetic Resonance Imaging (MRI) of the Inner Ear in Revealing Endolymphatic Hydrops (EH) in Patients With Certain or Probable Meniere's Disease (MD)
The aim of this study is to compare 3 methods for the diagnosis of endolymphatic hydrops (EH) in patients with Meniere's disease: MRI 3 Tesla (to visualise EH directly), and functional explorations, namely electrocochleography and dephasing of acoustic distortion products (which are modified by the EH).
The research hypothesis is that the examinations will show agreement in the diagnosis of EH, and that the results obtained (quantitative values) will vary in the same direction over time and during flares of MD.
- Conditions
- Endolymphatic Hydrops
- Being tested
- MRI 3T
- Medical subject headings
- Endolymphatic Hydrops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI 3TDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Certain or probable Meniere's disease | Experimental | Not described Receives: Diagnostic Test: MRI 3T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography
Measured: day one
Number of patients for whom an endolymphatic hydrops was diagnosed by (Dephasing) of acoustic distortion products
Measured: day one
Number of patients for whom an endolymphatic hydrops was diagnosed by 3T MRI 3T
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start8 Sep 2016
- Primary completion3 Jul 2018
- Study completion3 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endolymphatic HydropsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215420
- Sponsor's protocol ID
- DIORFLAR- BOZORG 2016
- Acronym
- MRI Meniere
- Status last verified
- Feb 2024
- First submitted
- 26 Jun 2017
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Agreement of Electrophysiological Audiovestibular Examinations With Magnetic Resonance Imaging (MRI) of the Inner Ear in Revealing Endolymphatic Hydrops (EH) in Patients With Certain or Probable Meniere's Disease (MD)
- ClinicalTrials.gov ID
- NCT03215420
- Acronym / sponsor ID
- MRI Meniere / DIORFLAR- BOZORG 2016
- Conditions
- Endolymphatic Hydrops
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 8 Sep 2016 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 12 Jul 2017 (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.
The aim of this study is to compare 3 methods for the diagnosis of endolymphatic hydrops (EH) in patients with Meniere's disease: MRI 3 Tesla (to visualise EH directly), and functional explorations, namely electrocochleography and dephasing of acoustic distortion products (which are modified by the EH).
The research hypothesis is that the examinations will show agreement in the diagnosis of EH, and that the results obtained (quantitative values) will vary in the same direction over time and during flares of MD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Certain or probable Meniere's disease | Experimental | Diagnostic Test: MRI 3T |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- persons who have provided written consent
- persons aged 18 to 75 years
- persons with certain, probable or possible Meniere's disease according to the international classification AAO-HNS
Key exclusion criteria (7 listed)
- persons without health insurance cover
- adults under guardianship
- persons with a history of hypersensitivity to the active substance or to one of the excipients of the contrast agent used for the MRI or to any gadolinium chelate
- pregnant or breast-feeding women
- severe acute or chronic kidney failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI 3T | Diagnostic test | Certain or probable Meniere's disease |
Primary outcome
Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography
Time frame: day one
Number of patients for whom an endolymphatic hydrops was diagnosed by (Dephasing) of acoustic distortion products
Time frame: day one
Number of patients for whom an endolymphatic hydrops was diagnosed by 3T MRI 3T
Time frame: day one
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI 3T in people with Endolymphatic Hydrops, run by Centre Hospitalier Universitaire Dijon 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 7 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: finished, as of the sponsor's last update on 22 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography (time frame: day one). The study lists 3 primary outcomes in all. 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 22 Feb 2024.