J38.03
Conditions
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion 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 • Patients who underwent at least one permanent glottal enlargement. If revision surgeries were performed, they should have been conducted on the same side of the original surgery • With sufficient autonomous respiratory capacity to maintain their vital functions independent 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 • The PCA innervating the vocal fold that never underwent a permanent glottal enlargement responds to electrical stimulation (clear abduction of the respective VF in response to electrical stimulation) within an ECE50 test. • Fluent in German
Exclusion criteria
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 bilateral 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 - Connection of the SPIRION Implant with the external SPIRION Processor • Patients wearing an active implantable medical device at the time of enrolment • Patients with a clinical history that would suggest a high probability that they would need an MRI • Patients diagnosed with a malignant disease in the head and neck region • Patients diagnosed with chronic airway infections or obstructions, or severe respiratory diseases (e.g., COPD grade II or higher) • Patients who underwent external beam radiation therapy in the surgical area • Patients diagnosed with a serious coagulation disorder requiring an uninterruptable use of anticoagulants • Patients with known allergies to the SPIRION Laryngeal Pacemaker material in direct contact with the human body • Patients suffering from moderate depression (BDI-II 20 or higher) or any other psychological or psychiatric disease • Any anatomic, physiological, or medical conditions that may increase the risks linked to the SPIRION Laryngeal Pacemaker implantation and/or reduce its benefit for the patient • Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of this clinical investigation • Anything that, in the opinion of the Principal Investigator, would place the patient at increased risk or preclude the patient's full compliance with the general requirements of this clinical investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • “The SPIRION Laryngeal Pacemaker System is safe” i.e. : - The SPIRION Laryngeal Pacemaker implantation does not associate with the occurrence of SADEs and/or of ADEs/DDs outside the expected range - The daily use of the SPIRION Laryngeal Pacemaker does not associate with the occurrence of SADEs and/or of ADEs/DDs outside the expected range - The daily use of the SPIRION Processor does not associate with the occurrence of SADEs and/or of ADEs/DDs outside the expected range • “The SPIRION Laryngeal Pacemaker System improves the patient’s respiratory patency” i.e. : At 12 months (Visit 07) the average normalized PIF is significantly greater than that obtained at baseline (Visit 00). | — |
Secondary
| Measure | Time frame |
|---|---|
| Voice quality It is expected that each of the following parameters and derived variables, assessed separately, will increase overtime from activation (Visit 02) to 6-months post activation (Visit 05) and remain stable thereafter: • Normalized Fundamental Frequency (F0) range • Sound Pressure Level (SPL) range • Maximum Phonation Time (MPT) While the following parameters should show a decrease over the same time range. • Jitter in percentage • Roughness, Breathiness, Hoarseness (RBH) The Dysphonia Severity Index (DSI) should score within 1.6 and 5 by 6-month post activation (Visit 05) and remain stable thereafter. The Voice Handicap Index (VHI)-9 questionnaire answers should show a score that does not significantly change or even decreases from baseline (Visit 00) to 12-months post activation (Visit 07) and remains stable thereafter. Respiratory patency It is expected that each of the following spirometry parameters and derived variables, assessed separately, will increase overtime from activation to 12-month post activation (Visit 07) and remain stable thereafter: • Absolute PEF, PIF, VC, FEV1, FVC • Normalized PEF, PIF, VC, FEV1, FVC • Tiffeneau Index: (FEV1/FVC)*100 • Phonation quotient (PQ): VC/MPT • Estimated Mean Flow Rate (EMFR): 77+0.236*PQ In addition, it is expected that the average PEF-meter values (absolute and normalized) will increase over time from activation (Visit 02) to 6-month post activation (Visit 05) and remain stable thereafter. The St. George's Respiratory Questionnaire (SGRQ) answers should show a score that decreases from baseline (Visit 00) to 12-month post activation (Visit 07) and remains stable thereafter. The SGRQ scoring should show an inverse proportionality with VC, FEV1, 6MWT, and PAM scores. Physical activity The • 6 Minute Walk Test (6MWT) and at least the • Physical Activity Monitor (PAM) results for the physical activity should increase from baseline (Visit 00) to 6-month post activation (Visit 05) a | — |
Countries
Austria, Germany
Contacts
Public ContactPia Plattner
MED-EL Elektromedizinische Geräte GmbH
Outcome results
None listed