Status:
RECRUITING
Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode (ECE50)
Lead Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Conditions:
Vocal Fold Paresis
Laryngeal Dystonia
Eligibility:
All Genders
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 16 2031
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT05245942
Start Date
December 16 2021
End Date
December 16 2031
Last Update
March 6 2025
Active Locations (1)
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1
Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten
Vienna, Austria, 1090