G47.31
Conditions
Interventions
Group 1: The aim of this clinical investigation is to determine whether the direct electrostimulation of the iSLN is able to increase the activity of the ipsilateral and potentially also the contralat
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age = 18 years • Patients who, independently from the enrollment in this clinical investigation, are pre-scheduled for an ENT surgery (such as laryngectomies or neck dissections) for which the iSLN exposure is foreseen and for whom, as a consequence of the said pre-scheduled ENT surgery the post-operative functionality of the exposed iSLN is irrelevant • Anatomic, physiological and mental conditions compatible with the participation in this clinical investigation • Signed and dated informed consent before the start of any clinical investigation-specific procedure for all the recruited subjects
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 (e.g. other types of dystonia, tremors, etc.) • Use of an active medical implant • Known allergies or intolerance to the material used for this clinical investigation • Parallel participation in a device/drug clinical investigation in the period of data collec-tion, which could confound the results of the clinical investigation 2019CIP001 • 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 |
|---|---|
| EMG of the genioglossus muscle activity for maximal 1 hour during the direct stimulation of the iSLN (internal Ramus of the superior laryngeal nerve) | — |
Secondary
| Measure | Time frame |
|---|---|
| EMG record of the musculus palatopharyngeus and musculus palatoglossus activity for maximal 1 hour during the direct stimulation of the iSLN (internal Ramus of the superior laryngeal nerve); Video of the stimulation; Stimulation report regarding the tested stimulation settings | — |
Countries
Germany
Contacts
Public ContactJoachim T. Maurer
"Klinik für Hals-Nasen-Ohrenheilkunde,Medizinische Fakultät Mannheim der Universität Heidelberg - Universitätklinikum Mannheim
Outcome results
None listed