NCT06910865

Brief Summary

In patients presenting with symptoms of endolymphatic hydrops, signs of vestibular dilation are often found on MRI. Some patients present with these radiological signs without vestibular clinical signs, or signs other than those of hydrops. No study has yet investigated the radiological-clinical correlation of endolymphatic hydrops by selecting patients based on their imaging findings and then comparing them to the symptoms presented.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2025

Completed
Last Updated

April 4, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

March 28, 2025

Last Update Submit

March 28, 2025

Conditions

Endolymphatic Hydrops

Keywords

Endolymphatic Hydrops

Outcome Measures

Primary Outcomes (1)

  • Nystagmus observed on videonystagmoscopy

    Nystagmus observed on videonystagmoscopy: * Unidirectional or multidirectional * Direction * Exhaustible or not * Perceptible or not

    Up to 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult subject (≥18 years) presenting vestibular dilation on MRI

You may qualify if:

  • Adult subject (≥18 years)
  • Subject presenting vestibular dilation on MRI

You may not qualify if:

  • Subjects who have expressed opposition to the reuse of their data for scientific research purposes.
  • Subjects under legal protection
  • Subjects under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Endolymphatic Hydrops

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Christian DEBRY, MD, PhD

CONTACT

33 3 88 12 76 44christian.debry@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 4, 2025

Study Start

July 19, 2024

Primary Completion

December 19, 2025

Study Completion

December 19, 2025

Last Updated

April 4, 2025

Record last verified: 2025-03

Locations

FR(1)