NCT03215420

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2018

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

June 26, 2017

Last Update Submit

February 21, 2024

Conditions

Endolymphatic Hydrops

Outcome Measures

Primary Outcomes (3)

  • Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography

    day one

  • Number of patients for whom an endolymphatic hydrops was diagnosed by (Dephasing) of acoustic distortion products

    day one

  • Number of patients for whom an endolymphatic hydrops was diagnosed by 3T MRI 3T

    day one

Study Arms (1)

Certain or probable Meniere's disease

EXPERIMENTAL
Diagnostic Test: MRI 3T

Interventions

MRI 3TDIAGNOSTIC_TEST
Certain or probable Meniere's disease

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHu Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Conditions

Endolymphatic Hydrops

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 12, 2017

Study Start

September 8, 2016

Primary Completion

July 3, 2018

Study Completion

October 3, 2018

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)