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

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

Study Overview

• Status: Recruiting
• Conditions: Laryngeal Dystonia; Vocal Fold Paresis

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 Type: Observational
• Enrollment (Estimated): 384

Contacts and Locations

• Study Contact: Name: Pia Plattner, MSc; Phone Number: +43 664 6070 51681; Email: pia.plattner@medel.com
• Study Contact Backup: Name: Cristina Rubiolo, Dr.; Phone Number: +43 664 6070 5556; Email: cristina.rubiolo@medel.com

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten
    • Contact: Berit Schneider-Stickler, Prof.Dr.med.; Phone Number: +43 140 400 3310; Email: berit.schneider-stickler@meduniwien.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

• Target population: adults of both sexes who, in the expert opinion of the registry responsible is in need of an ECE50 examination
• Accessible population: target population matching the selection criteria
• Intended population: accessible population that can be recruited by the registry sites
• Actual population: intended population who signed the ICF
• Analytic population: actual population compatible with PP analysis

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardize the medical procedure for the ECE50	Descriptive evaluation of the ECE50 stimulation protocol	Immediately after the intervention

Collaborators and Investigators

• Sponsor: MED-EL Elektromedizinische Geräte GesmbH
• Investigators: Principal Investigator: Berit Schneider-Stickler, Prof.Dr.med., Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten, Vienna

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): December 16, 2026

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Dystonia; Paresis
• Other Study ID Numbers: 2021REG002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No