Active — Not RecruitingNot Applicable

Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode (ECE50)

Austria384 participantsStarted 2021-12-16

Plain-language summary

The objective of this registry is to confirm the safety and the performance of the ECE50 in medical routine by collecting data.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Confirm the safety

Timeframe: Immediately after the intervention

Assess the performance of the ECE50

Timeframe: During the intervention

Trial details

NCT IDNCT05245942

SponsorMED-EL Elektromedizinische Geräte GesmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-02-01

View on ClinicalTrials.gov More Vocal Fold Paresis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.