J38.01
Conditions
Interventions
Group 1: Intra-operative low voltage electrical stimulation directly delivered on the exposed TA muscle or innervating branch of the RLN ipsilateral to the ailing vocal fold in UVFP patients, during t
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age = 18 • Diagnosed UVFP and scheduled for a routine surgery to treat UVFP symptoms (e.g. laryngeal framework surgery or reinnervation of the ailing VF) • 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the method measured by number of AEs, medialisation of the VF in reaction to stimulation observed using videolaryngoscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| stimulation parameters used to determine the combination that elicits optimal vocal fold medialization; correlation between pre-OP laryngeal EMG (LEMG) data and optimal stimulation parameters | — |
Countries
Germany
Contacts
Public ContactMarkus M. Hess
Deutsche Stimmklinik (im "Sepctrum" - auf dem Gelände des UKE)
Outcome results
None listed