DRKS00020136
Completed
未知
Evaluation of the ailing vocal fold response to external, surface electrostimulation in patients suffering from unilateral vocal fold paralysis (UVFP)
MED-EL Elektromedizinische Geräte GmbH0 sites54 target enrollmentJanuary 9, 2020
ConditionsJ38.01
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- J38.01
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Enrollment
- 54
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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