Clinical trial NCT05245942: Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode (ECE50)
Official title: Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode (ECE50)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vocal Fold Paresis
Laryngeal Dystonia
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
First posted: 2022-02-18
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Confirm the safety
timeFrame: Immediately after the intervention
measure: Assess the performance of the ECE50
timeFrame: During the intervention
Secondary outcomes:
measure: Standardize the medical procedure for the ECE50
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten
Study officials:
affiliation: Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten, Vienna
name: Berit Schneider-Stickler, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: