An interventional study of SPIRION Laryngeal Pacemaker System Implantation and follow-up in Bilateral Vocal Cord Paralysis, sponsored by MED-EL Elektromedizinische Geräte GesmbH. Terminated at 6 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by MED-EL Elektromedizinische Geräte GesmbH · Not applicable, Interventional, and Treatment
The goal of this clinical investigation is to learn about the use of a novel medical device, the SPIRION Laryngeal Pacemaker, in patients suffering from bilateral vocal fold paralysis (BVFP) and who have had at least one related surgery on one of their vocal folds. The main questions it aims to answer are:
Participants will be implanted with the SPIRION Laryngeal Pacemaker and the development of their symptoms will be observed for the following 2 years.
This clinical investigation aims to assess the long-term safety and performance of the SPIRION Laryngeal Pacemaker. The SPIRION Laryngeal Pacemaker is a new active implantable medical device designed and developed by MED-EL Elektromedizinische Geräte GmbH. It is currently in its pre-market approval phase and the results of this clinical investigation will be used to apply for EU market entry.
The SPIRION Laryngeal Pacemaker is intended to improve the symptoms of Bilateral Vocal Fold Paralysis (BVFP) patients with respiratory symptoms severe enough to require surgical treatment.
The SPIRION Laryngeal Pacemaker consists of 2 implantable (the SPIRION Electrode and the SPIRION Implant) and 1 external (the SPIRION Processor) components. The SPIRION Electrodes and the SPIRION Implant are placed subcutaneously in the neck and above the sternum, respectively. The SPIRION Processor is placed on the skin above the sternum.
The external SPIRION Processor transmits the stimulation parameters to the SPIRION Implant, which in turn transmits the stimulation via the SPIRION Electrode to the posterior cricoarytenoid muscle (PCA). The PCA stimulation induces the lateralization (abduction) of the respective vocal fold (VF) and thus increases the glottal gap and improves respiratory patency.
Each patient is foreseen to actively participate in this clinical investigation for a maximum of 28 months. Patients will be offered participation by their ear, nose, and throat specialist. In case a patient is interested, a thorough Informed consent process will be initiated. Patients will be tested for eligibility and if they pass, the baseline values regarding respiration, voice, and other symptoms will be recorded. A few days to weeks later, the SPIRION Laryngeal Pacemaker is implanted. The Implant is activated about 2 to 4 weeks after a successful implantation and is fitted to the individual needs of the patient. Subsequent follow-up (FU) visits are conducted after about 1, 3, 6, 9, 12, 18, and 24 months after the activation of the device. The results of the various tests meant to assesses the patients' quality of respiration, voice, and other symptoms are recorded. The SPIRION Laryngeal Pacemaker will be transiently deactivated twice between 12 and 24 months after activation. Tests will be performed in this period and compared with the previous and subsequent tests performed with the active device. In addition, patients' activity before implantation and during the 24-month FU period will be regularly assessed. Upon study conclusion, the patients will be actively followed-up every 6 months until the SPIRION Laryngeal Pacemaker receives a CE certification, or it is surgically removed.
The implantation of the SPIRION Laryngeal Pacemaker should generally improve the BVFP symptoms of patients regarding respiration, swallowing, and sleep quality. Voice quality should not be affected or even improve. Moderate physical activity (e.g., using an E-bike) should become possible, leading to an improved general quality of life.
Unlike surgical glottal enlargement, the implantation of the SPIRION Laryngeal Pacemaker should not lead to problems with swallowing and aspiration. In addition, it should lead to a lesser rate and /or severity of surgical complications and surgery-related side-effects.
MED-EL Elektromedizinische Geräte GesmbH is the lead sponsor of 35 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
General information
The following patient categories can be recruited into this clinical investigation if they comply with all the selection criteria:
Inclusion Criteria:
Exclusion Criteria:
Patients who underwent thoracic surgeries that would compromise at least one of the following procedures:
SPIRION Laryngeal Pacemaker System Implantation and follow-up
Device: SPIRION Laryngeal Pacemaker System Implantation and follow-up
Timeline of Visits * Screening * Baseline: Official baseline, assessment primary \& secondary objectives * Implantation of device * Activation \& fitting: Baseline active device; implanted device has just been activated; assessment of secondary objectives only * 8 FU Visits over 2 years after activation; Includes * Baseline Switch Off: results of the visit preceding a 14-day switch-off of the device; assessment of secondary objectives only * Endpoints for * Pivotal phase: 12 months after activation; official endpoint for assessment of primary \& secondary objectives * Active post-pivotal phase: 24-month follow-up; endpoint for all secondary objectives * Switch Off: 2 Visits; assessment of secondary objectives only * Repeated checkpoints to assess device effects over 2 years: 5 visits; assessment of secondary objectives only Device shall increase respiratory patency during inspiration, assessed by normalized PIF; other outcome measures are used to assess secondary objectives
Device Safety
Number of Adverse Events (AEs), Serious Adverse Device Effect (SADEs), and Device Deficiencies (DDs)
Time frame: 12 Months
Device Performance - Respiration
PIF (Peak Inspiratory Flow) \[L/min\]
Time frame: 12 Months
Voice Quality - Fundamental Frequency (F0)
F0 range \[Hz\]
Time frame: 24 months
Voice Quality - Sound Pressure Level (SPL)
SPL range \[dB\]
Time frame: 24 months
Voice Quality - Maximum Phonation Time (MPT)
MPT \[s\]
Time frame: 24 months
Voice Quality - Jitter
Jitter in percentage \[%\]
Time frame: 24 months
Voice Quality - Roughness, Breathiness, Hoarseness (RBH)
RBH - score between 0 and 3 for each characteristic, higher score indicates worse voice quality
Time frame: 24 months
Voice Quality - Dysphonia Severity Index (DSI)
DSI - calculated as 0,13 \* MPT + 0,0053 \* F0\_maximal - 0,26 \* SPL\_minimal - 1,18 \* Jitter + 12,4; the following ranges apply: abnormal voice (-5 \< X ≤ 1,6); normal voice (1,6 \< X ≤ 5), not evaluable (≤ -5)
Time frame: 24 months
Voice Quality - Voice Handicap Index (VHI)-9
VHI-9 patient questionnaire - score between 0 and 36, higher score indicates worse voice quality)
Time frame: 24 months
Respiratory patency - Absolute Peak Expiratory Flow (PEF)
Absolute PEF \[L/min\]
Time frame: 24 months
Respiratory patency - Normalized PEF
Normalized PEF \[L/min\]
Time frame: 24 months
Respiratory patency - Absolute Peak Inspiratory Flow (PIF)
Absolute PIF \[L/min\]
Time frame: 24 months
Respiratory patency - Normalized PIF
Normalized PIF \[L/min\]
Time frame: 24 months
Respiratory patency - Absolute Vital Capacity (VC)
Absolute VC \[L\]
Time frame: 24 months
Respiratory patency - Normalized VC
Normalized VC \[L\]
Time frame: 24 months
Respiratory patency - Absolute Forced Expiratory Volume in one second (FEV1)
Absolute FEV1 \[L\]
Time frame: 24 months
Respiratory patency - Normalized FEV1
Normalized FEV1 \[L\]
Time frame: 24 months
Respiratory patency - Absolute Forced Vital Capacity (FVC)
Absolute FVC \[L\]
Time frame: 24 months
Respiratory patency - Normalized FVC
Normalized FVC \[L\]
Time frame: 24 months
Respiratory patency - Tiffeneau Index
Tiffeneau Index - calculated as (FEV1/FVC)\*100
Time frame: 24 months
Respiratory patency - Phonation quotient (PQ)
PQ - calculated as VC/MPT \[L/s\]
Time frame: 24 months
Respiratory patency - Estimated Mean Flow Rate (EMFR)
EMFR - calculated as 77+0.236\*PQ
Time frame: 24 months
Respiratory patency - St. George's Respiratory Questionnaire (SGRQ)
SGRQ patient questionnaire - score between 0 and 100; higher score indicates worse health
Time frame: 24 months
Physical activity - 6 Minute Walk Test (6MWT)
6MWT \[m\]
Time frame: 24 months
Physical activity - Physical Activity Monitor (PAM) - Physical activity level (PAL)
PAL - calculated as Total Energy Expenditure \[Kcal\]/Basal Metabolic Rate\[Kcal\]
Time frame: 24 months
Physical activity - PAM - Activity/Rest durations
Durations of activity/inactivity/sleep measured in \[h:m\] and \[%\]
Time frame: 24 months
Physical activity - PAM - Movement intensity
Movement intensity \[g\]
Time frame: 24 months
Physical activity - PAM - Number of steps
Average Number of steps per 24 h
Time frame: 24 months
Physical activity - PAM - Times out of bed
Number of Times out of bed
Time frame: 24 months
Swallow quality
MD Anderson Dysphagia Inventory (MDADI) patient questionnaire - total score between 20 and 100, higher score indicates better day-to-day functioning
Time frame: 24 months
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) patient questionnaire - score between 0 and 21; higher score indicates worse sleep quality
Time frame: 24 months
Participant's Quality of Life - Short Form-36 (SF-36) questionnaire
SF-36 patient questionnaire - score between 0 and 100, higher score indicates better health
Time frame: 24 months
Participant's Quality of Life - Glasgow Benefit Inventory (GBI)
GBI patient questionnaire - score between -100 and 100, negative scores indicate a poor outcome, positive scores indicate a good outcome
Time frame: 24 months
Symptoms
Symptom form - Log of symptoms and symptom severity during visits, descriptive evaluation
Time frame: 24 months
Symptoms and Patient Observations
Weekly Journal - Log of symptoms, symptom severity, and device use at home, descriptive evaluation
Time frame: 24 months
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