Comparison of 3 Methods to Diagnose Endolymphatic Hydrops... | NCT03215420

Studies
Comparison of 3 Methods to Diagnose Endolymphatic Hydrops in Meniere's Disease

NCT03215420

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Feb 22, 2024Actual

Enrollment

41Actual

Phase

Not Applicable

Conditions

Endolymphatic Hydrops

Interventions

MRI 3T

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 8, 2016Actual

Primary Completion Date

Jul 3, 2018Actual

Completion Date

Oct 3, 2018Actual

First Submitted Date

Jun 26, 2017

First Submission Date that Met QC Criteria

Jul 10, 2017

First Posted Date

Jul 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2024

Last Update Posted Date

Feb 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Label	Type	Description	Intervention Names
Certain or probable Meniere's disease	Experimental		Diagnostic Test: MRI 3T

Name	Type	Description	Arm Group Labels	Other Names
MRI 3T	Diagnostic Test		Certain or probable Meniere's disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHu Dijon Bourgogne		Dijon		21079	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018159	Endolymphatic Hydrops

Ancestor Terms

ID	Term
D007759	Labyrinth Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided