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Clinical Trial Summary

The objective of this registry is to confirm the safety and the performance of the ECE50 in medical routine by collecting data.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05245942
Study type Observational [Patient Registry]
Source MED-EL Elektromedizinische Geräte GesmbH
Contact Pia Plattner, MSc
Phone +43 664 6070 51681
Email pia.plattner@medel.com
Status Recruiting
Phase
Start date December 16, 2021
Completion date December 16, 2026

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