Evaluation of the ailing vocal fold response to external, surface electrostimulation in patients suffering from unilateral vocal fold paralysis (UVFP)

Not Applicable

• Conditions: J38.01

• Registration Number: DRKS00020136
• Lead Sponsor: MED-EL Elektromedizinische Geräte GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-09
• Results First Posted: 2021-04-02
• Study Completion: 2021-10-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Age = 18
• Diagnosed UVFP within the last month
• Anatomic, physiological and mental conditions compatible with the participation in this clinical investigation
• High motivation with realistic expectations regarding the participation in this clinical investigation
• Signed and dated informed consent before the start of any study specific assessment

Exclusion Criteria

• Lack of compliance with any inclusion criteria
• Pregnant or breast-feeding women
• Other clinical diseases that might result in alteration of the outcomes of this clinical investigation, in particular vocal fold-related disorders (e.g. cartilage arthroses), airwayrelated diseases (e.g. Asthma or COPD) or other muscular diseases
• Use of an active implant
• Known allergies or intolerance to the material used for this clinical investigation
• Current participation in other drugs and/or medical device studies that can affect the results of the present clinical investigation
• Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Safety profile<br>• Videoendolaryngo(strobo)scopy<br><br>The videoendolaryngo(strobe)scopy will be conducted at the test session and 1, 3 and 6 months after the test session.

Secondary Outcome Measures

Name	Time	Method
Stimulation parameters used to determine the combination that elicits optimal vocal fold medialization; correlation between a routine EMG and optimal stimulation parameters