Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode (ECE50)

Launched by MED-EL ELEKTROMEDIZINISCHE GERÄTE GESMBH · Feb 17, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a device called the Endoscopic Cap Electrode (ECE50) for treating conditions related to vocal fold problems, specifically vocal fold paresis and laryngeal dystonia. The goal is to gather information on how well this device works in real-life medical settings. The trial is currently recruiting participants, and anyone between the ages of 18 and 74 who has a diagnosed issue with the muscles in their throat may be eligible to join.

To participate, individuals must be adults who can provide informed consent, meaning they understand the study and agree to take part. However, some people may not qualify, such as those with certain medical implants, known allergies to the materials used, or those already involved in another similar study. If eligible, participants can expect to contribute to valuable research that could help improve treatments for vocal fold disorders while being monitored for their safety throughout the study.

Gender

ALL

Eligibility 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