NCT05245942

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 384 (estimated)
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 safety and performance of the Endoscopic Cap in medical routine. Subject's participation will last a maximum of 2 hours. Upon successful conclusion of the screening session starts the testing session of the ECE50. The ECE50 has been designed to be placed on the top of a videoendoscope for the delivery of electrostimulation to the laryngeal region. The stimulation and reaction of the muscles can provide information about the presence and type of dysfunctions and thus influence the treatment procedure. Being a registry a collection of records generated within routine medical procedures with a medical device approved for the EU market, it does not pose additional risks for the patients participating in it.

Conditions

• Vocal Fold Paresis
• Laryngeal Dystonia

Timeline

• Start date: 2021-12-16
• Primary completion: 2027-02-01
• Completion: 2031-12-16
• First posted: 2022-02-18
• Last updated: 2026-01-16

Locations

1 site across 1 country: Austria