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The objective of this registry is to confirm the safety and the performance of the ECE50 in medical routine by collecting data.
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.
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Standardize the medical procedure for the ECE50 | Descriptive evaluation of the ECE50 stimulation protocol | Immediately after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berit Schneider-Stickler, Prof.Dr.med. | Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten, Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ. Klinik für Hals-, Nasen- und Ohrenkrankheiten | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D055154 | Dysphonia |
| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |