Monitoring of the safety and the performance of the Endoscopic Cap electrode (ECE50)

Recruiting

• Conditions: J38; Diseases of vocal cords and larynx, not elsewhere classified

• Registration Number: DRKS00027395
• Lead Sponsor: MED-EL Elektromedizinische Geräte GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>• Clinical routine<br>• Clinical Investigations

Secondary Outcome Measures

Name	Time	Method
The secondary objective of this registry is<br>• 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.