J38
Conditions
Interventions
Group 1: Since this is an observatory study, diagnosis, treatment and follow-ups follow the standard procedures of the respective clinic. The patient data will be collected to be evaluated in the regi
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this registry is to confirm the safety and the performance of the ECE50 used according to its manual by collecting real life data concerning its use in: • Clinical routine • Clinical Investigations | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this registry is • to standardize the medical procedure for the use of the ECE50 across the hospitals in order to allow easy comparison of the safety and performance results of the device. | — |
Countries
Austria
Contacts
Public ContactPia Plattner
MED-EL Elektromedizinische Geräte GmbH
Outcome results
None listed