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New device aims to improve diagnosis of voice disorders

NCT ID NCT05245942

Diagnosis Sponsor: MED-EL Elektromedizinische Geräte GesmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is tracking the safety and performance of a device called ECE50 used during routine medical exams. It involves 384 adults who need a diagnosis for voice box muscle issues, like vocal fold paresis or laryngeal dystonia. The goal is to see if the device works as well as standard tests and to standardize how it is used.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 384 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

* Target population: adults of both sexes who, in the expert opinion of the registry responsible is in need of an ECE50 examination * Accessible population: target population matching the selection criteria * Intended population: accessible population that can be recruited by the registry sites * Actual population: intended population who signed the ICF * Analytic population: actual population compatible with PP analysis

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Legal adults (i.e., as a general rule patients ≥ 18 years old) * Legal adults requiring a diagnosis for a disorder that could be traced back to uni- or bilateral dysfunction of one or more laryngeal muscle(s) of the posterior cricoid region * Signed and dated informed consent before the start of any registry-specific procedure for all the recruited subjects Exclusion Criteria: * Lack of compliance with any inclusion criteria * Use of an active medical implant * Known allergies or intolerance to the material used for this registry * Parallel participation in a device/drug registry in the period of data collection, which could confound the results of the registry * Anything that, in the opinion of the Registry Responsible, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this registry

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Conditions

The condition(s) this trial relates to.

spasmodic dystonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Laryngeal dystonia Vocal fold paresis

Contacts and locations

Locations

  • Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten

    Vienna, 1090, Austria

More trials for these conditions

Other studies related to the condition(s) this trial covers.