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

NCT05245942 | Active Not Recruiting

• 1 other identifier: 2021REG002
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vocal Fold Paresis; Laryngeal Dystonia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Standardize the medical procedure for the ECE50

  Immediately after the intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (1)

Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Berit Schneider-Stickler, Prof.Dr.med.

  Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten, Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: February 18, 2022
• Study Start: December 16, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 16, 2031
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

AU (1)