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

Laryngeal Dystonia Clinical Trial

— ECE50  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05245942
• Other study ID #: 2021REG002
• Status: Recruiting
• Start date: December 16, 2021
• Est. completion date: December 16, 2026

Study information

• Verified date: March 2024
• Source: MED-EL Elektromedizinische Geräte GesmbH
• Contact: Pia Plattner, MSc
• Phone: +43 664 6070 51681
• Email: pia.plattner[@]medel.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: December 16, 2026
• Est. primary completion date: February 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dystonia
• Laryngeal Dystonia
• Paresis

Locations

Country	Name	City	State
Austria	Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
MED-EL Elektromedizinische Geräte GesmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirm the safety	Adverse event report analysis	Immediately after the intervention
Primary	Assess the performance of the ECE50	Comparison between the result of the ECE50 stimulation, Laryngeal Electromyography (LEMG), videolaryngoscopy	During the intervention
Secondary	Standardize the medical procedure for the ECE50	Descriptive evaluation of the ECE50 stimulation protocol	Immediately after the intervention