DRKS00032341
Recruiting
Phase 3
nilateral implantation of the SPIRION Laryngeal Pacemaker in patients without previous permanent glottal enlargement
MED-EL Elektromedizinische Geräte GmbH0 sites20 target enrollmentJuly 24, 2023
ConditionsJ38.03
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- J38.03
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General information
- •The following patient categories can be recruited into this clinical investigation if they comply with all the selection criteria:
- •Patients recruited in the previous FIH clinical investigation 2011CIP001
- •Patients with an open tracheostoma at the time of enrolment
- •Inclusion Criteria:
- •Between 18 and 75 years old at the time of enrolment (i.e., ICF signed)
- •Diagnosed with BVFP for a minimum of 6 months
- •With sufficient autonomous respiratory capacity to maintain their vital functions independently of the SPIRION Laryngeal Pacemaker. Before a permanent closure of the tracheostomy is carried out during this clinical investigation, the Principal Investigator shall confirm that at least at rest, the failure of the SPIRION Laryngeal Pacemaker would not put the patient in a life\-threatening condition because of insufficient respiratory patency
- •At least one PCA responds to electrical stimulation (clear abduction of the respective VF in response to electrical stimulation) within an ECE50 test, or shows reinnervation in an LEMG assessment
- •Fluent in German.
Exclusion Criteria
- •Lack of compliance with any inclusion criteria
- •Pregnant or breast\-feeding women
- •Patients suffering from an ongoing or chronic laryngeal inflammation at the time of enrolment
- •Vocal fold immobility caused by arytenoid joint dysfunctions (e.g., arthritis, scarring, etc.), malignancies, CNS pathologies, and/or systemic diseases
- •Patients who underwent previous permanent surgical glottal enlargement
- •Patients who underwent any other laryngeal surgeries (e.g., laryngeal framework surgery) that would compromise the correct SPIRION Electrode placement and/or the intended functionality of the SPIRION Laryngeal Pacemaker
- •The adductor laryngeal muscles on either or both sides underwent a botulinum toxin injection that is still effective at the time of surgery (i.e., the respective VF position is either in intermediate or lateral position)
- •Patients who underwent thoracic surgeries that would compromise at least one of the following procedures:
- •\- Correct placement of the SPIRION Electrode or SPIRION Implant
- •\- Connection of the SPIRION Implant with the SPIRION Electrode
Outcomes
Primary Outcomes
Not specified
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