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

Recruiting

• Conditions: Laryngeal Dystonia; Vocal Fold Paresis

• Registration Number: NCT05245942
• Lead Sponsor: MED-EL Elektromedizinische Geräte GesmbH

Brief 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.

Study Timeline

• Study Start: 2021-12-16
• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Primary Completion: 2027-02-01
• Study Completion: 2031-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 384

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
Confirm the safety	Immediately after the intervention	Adverse event report analysis
Assess the performance of the ECE50	During the intervention	Comparison between the result of the ECE50 stimulation, Laryngeal Electromyography (LEMG), videolaryngoscopy

Secondary Outcome Measures

Name	Time	Method
Standardize the medical procedure for the ECE50	Immediately after the intervention	Descriptive evaluation of the ECE50 stimulation protocol

Trial Locations

Locations (1)

Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten; 🇦🇹 Vienna, Austria