Vocal Fold ParesisECE50NCT05245942
Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode (ECE50)
An observational study of Vocal Fold Paresis and Laryngeal Dystonia, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Austria.
Trial summary
The objective of this registry is to confirm the safety and the performance of the ECE50 in medical routine by collecting data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vocal Fold Paresis, Laryngeal Dystonia
- How many people
- 384 participants
- Where
- 1 siteAustria
- Study dates
- 16 Dec 2021to 16 Dec 2031
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten
Vienna, 1090
About this study
The objective of this registry is to confirm the safety and the performance of the ECE50 in medical routine by collecting data.
Read the detailed description
The Endoscopic Cap Electrode (ECE50) has been designed for the delivery of electrostimulation to selected laryngeal muscles. The primary objective of this registry is to retrieve real-life data on the safety and performance of the Endoscopic Cap in medical routine. Subject's participation will last a maximum of 2 hours. Upon successful conclusion of the screening session starts the testing session of the ECE50. The ECE50 has been designed to be placed on the top of a videoendoscope for the delivery of electrostimulation to the laryngeal region. The stimulation and reaction of the muscles can provide information about the presence and type of dysfunctions and thus influence the treatment procedure. Being a registry a collection of records generated within routine medical procedures with a medical device approved for the EU market, it does not pose additional risks for the patients participating in it.
- Conditions
- Vocal Fold Paresis, Laryngeal Dystonia
- Medical subject headings
- Dysphonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm the safety
Adverse event report analysis
Measured: Immediately after the intervention
Assess the performance of the ECE50
Comparison between the result of the ECE50 stimulation, Laryngeal Electromyography (LEMG), videolaryngoscopy
Measured: During the intervention
Secondary outcomes (1)
Standardize the medical procedure for the ECE50
Descriptive evaluation of the ECE50 stimulation protocol
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start16 Dec 2021
- Primary completion1 Feb 2027 (estimated)
- Study completion16 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Fold ParesisStudies of the same condition, open and under way.
- More trials run by MED-EL Elektromedizinische Geräte GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 384 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Berit Schneider-Stickler, Prof.Dr.med., Principal investigator, Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten, Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245942
- Sponsor's protocol ID
- 2021REG002
- Acronym
- ECE50
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2021
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode (ECE50)
- ClinicalTrials.gov ID
- NCT05245942
- Acronym / sponsor ID
- ECE50 / 2021REG002
- Conditions
- Vocal Fold Paresis, Laryngeal Dystonia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 16 Dec 2031 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this registry is to confirm the safety and the performance of the ECE50 in medical routine by collecting data.
Detailed description
The Endoscopic Cap Electrode (ECE50) has been designed for the delivery of electrostimulation to selected laryngeal muscles. The primary objective of this registry is to retrieve real-life data on the safety and performance of the Endoscopic Cap in medical routine. Subject's participation will last a maximum of 2 hours. Upon successful conclusion of the screening session starts the testing session of the ECE50. The ECE50 has been designed to be placed on the top of a videoendoscope for the delivery of electrostimulation to the laryngeal region. The stimulation and reaction of the muscles can provide information about the presence and type of dysfunctions and thus influence the treatment procedure. Being a registry a collection of records generated within routine medical procedures with a medical device approved for the EU market, it does not pose additional risks for the patients participating in it.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Confirm the safety
Time frame: Immediately after the intervention
Adverse event report analysis
Assess the performance of the ECE50
Time frame: During the intervention
Comparison between the result of the ECE50 stimulation, Laryngeal Electromyography (LEMG), videolaryngoscopy
1 secondary outcome
Standardize the medical procedure for the ECE50
Time frame: Immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Related trials for Vocal Fold Paresis
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Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures
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RecruitingObservational study
Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berit Schneider-Stickler, Prof.Dr.med. principal investigator
Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten, Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vocal Fold Paresis and Laryngeal Dystonia, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm the safety (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.