Monitoring the safety and performance of the Endoscopic Cap Electrode for laryngeal conditions
Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode (ECE50)
This study is testing a new device that uses electrostimulation to help people with laryngeal conditions, like vocal fold paresis and laryngeal dystonia, to see how well it works and if it's safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 384 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MED-EL Elektromedizinische Geräte GesmbH Industry-sponsored |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05245942 on ClinicalTrials.gov |
What this trial studies
This registry aims to collect real-life data on the safety and performance of the Endoscopic Cap Electrode (ECE50), which is designed to deliver electrostimulation to selected laryngeal muscles. Participants will undergo a screening session followed by a testing session lasting up to 2 hours, during which the ECE50 will be placed on a videoendoscope to assess muscle function and dysfunctions. The data collected will help inform treatment procedures for conditions like vocal fold paresis and laryngeal dystonia. As an observational registry, it poses no additional risks to participants beyond routine medical procedures.
Who should consider this trial
Good fit: Ideal candidates are legal adults aged 18 and older who require a diagnosis for laryngeal muscle dysfunction.
Not a fit: Patients with active medical implants or known allergies to the materials used in the registry may not benefit from participation.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding and treatment of laryngeal muscle dysfunctions, leading to improved patient outcomes.
How similar studies have performed: While this approach is observational and builds on existing medical practices, similar studies have shown promise in understanding laryngeal conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vienna
- Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Berit Schneider-Stickler, Prof.Dr.med. — Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten, Vienna
- Study coordinator: Pia Plattner, MSc
- Email: pia.plattner@medel.com
- Phone: +43 664 6070 51681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.