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Bilateral Vocal Cord ParalysisNCT06007170

Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement

A study testing SPIRION Laryngeal Pacemaker System Implantation and follow-up in people with Bilateral Vocal Cord Paralysis, run by MED-EL Elektromedizinische Geräte GmbH at 6 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Bilateral Vocal Cord Paralysis
What is being tested?
SPIRION Laryngeal Pacemaker System Implantation and follow-up
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
6 sitesin 2 countries
Study dates
27 Jul 2023to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between 18 and 75 years old at the time of enrolment (i.e., informed consent form (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 Endoscopic Cap Electrode (ECE50) test
  • Fluent in German.

Who cannot join

  • 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, central nervous system (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
Show all 22Show fewer
  • 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., chronic obstructive pulmonary disease (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 (Beck's Depression Inventory (BDI) ≥ 20) or any other psychological or psychiatric diseases
  • 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.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Germany4 sites

  • Charité - Medical University of Berlin

    Berlin, 10117

  • SRH Wald-Klinikum Gera GmbH

    Gera, Thuringia, 07548

  • Stuttgart Hospital - Katharinenhospital

    Stuttgart, Baden-Wurttemberg, 70174

  • University Hospital of Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

Austria2 sites

  • Tirol Kliniken GmbH

    Innsbruck, Tyrol, 6020

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: Unilateral Implantation of the SPIRION Laryngeal Pacemaker in Patients Without Previous Permanent Glottal Enlargement

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). The main questions it aims to answer are:

  • Is the use of the device safe?
  • Does the device improve the participants ability to take a breath?

Participants will be implanted with the SPIRION Laryngeal Pacemaker and the development of their symptoms will be observed for the following 2 years.

Read the detailed description

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 Electrode and the SPIRION Implant are placed below the skin 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 3 to 5 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.

Being tested
SPIRION Laryngeal Pacemaker System Implantation and follow-up
Keywords
Bilateral Vocal Fold Paralysis, BVFP, Bilateral Vocal Cord Paralysis, BVCP, Laryngeal Pacemaker, Electrical Stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPIRION Laryngeal Pacemaker System Implantation and follow-upDevice

    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
Study groups in NCT06007170
Study groupRoleWhat they receive
Treatment GroupExperimentalSPIRION Laryngeal Pacemaker System Implantation and follow-up
Receives: Device: SPIRION Laryngeal Pacemaker System Implantation and follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Device Safety

    Number of Adverse Events (AEs), Serious Adverse Device Effect (SADEs), and Device Deficiencies (DDs)

    Measured: 12 Months

  2. Device Performance - Respiration

    PIF (Peak Inspiratory Flow) [L/min]

    Measured: 12 months

Secondary outcomes (33)

  1. Voice Quality - Fundamental Frequency (F0)

    F0 range [Hz]

    Measured: 24 months

  2. Voice Quality - Sound Pressure Level (SPL)

    SPL range [dB]

    Measured: 24 months

  3. Voice Quality - Maximum Phonation Time (MPT)

    MPT [s]

    Measured: 24 months

  4. Voice Quality - Jitter

    Jitter in percentage [%]

    Measured: 24 months

  5. Voice Quality - Roughness, Breathiness, Hoarseness (RBH)

    RBH - score between 0 and 3 for each characteristic, higher score indicates worse voice quality

    Measured: 24 months

  6. 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)

    Measured: 24 months

  7. Voice Quality - Voice Handicap Index (VHI)-9

    VHI-9 patient questionnaire - score between 0 and 36, higher score indicates worse voice quality)

    Measured: 24 months

  8. Respiratory patency - Absolute Peak Expiratory Flow (PEF)

    Absolute PEF [L/min]

    Measured: 24 months

  9. Respiratory patency - Normalized PEF

    Normalized PEF [L/min]

    Measured: 24 months

  10. Respiratory patency - Absolute Peak Inspiratory Flow (PIF)

    Absolute PIF [L/min]

    Measured: 24 months

  11. Respiratory patency - Normalized PIF

    Normalized PIF [L/min]

    Measured: 24 months

  12. Respiratory patency - Absolute Vital Capacity (VC)

    Absolute VC [L]

    Measured: 24 months

  13. Respiratory patency - Normalized VC

    Normalized VC [L]

    Measured: 24 months

  14. Respiratory patency - Absolute Forced Expiratory Volume in one second (FEV1)

    Absolute FEV1 [L]

    Measured: 24 months

  15. Respiratory patency - Normalized FEV1

    Normalized FEV1 [L]

    Measured: 24 months

  16. Respiratory patency - Absolute Forced Vital Capacity (FVC)

    Absolute FVC [L]

    Measured: 24 months

  17. Respiratory patency - Normalized FVC

    Normalized FVC [L]

    Measured: 24 months

  18. Respiratory patency - Tiffeneau Index

    Tiffeneau Index - calculated as (FEV1/FVC)*100

    Measured: 24 months

  19. Respiratory patency - Phonation quotient (PQ)

    PQ - calculated as VC/MPT [L/s]

    Measured: 24 months

  20. Respiratory patency - Estimated Mean Flow Rate (EMFR)

    EMFR - calculated as 77+0.236*PQ

    Measured: 24 months

  21. Respiratory patency - St. George's Respiratory Questionnaire (SGRQ)

    SGRQ patient questionnaire - score between 0 and 100; higher score indicates worse health

    Measured: 24 months

  22. Physical activity - 6 Minute Walk Test (6MWT)

    6MWT [m]

    Measured: 24 months

  23. Physical activity - Physical Activity Monitor (PAM) - Physical activity level (PAL)

    PAL - calculated as Total Energy Expenditure [Kcal]/Basal Metabolic Rate[Kcal]

    Measured: 24 months

  24. Physical activity - PAM - Activity/Rest durations

    Durations of activity/inactivity/sleep measured in [h:m] and [%]

    Measured: 24 months

  25. Physical activity - PAM - Movement intensity

    Movement intensity [g]

    Measured: 24 months

  26. Physical activity - PAM - Number of steps

    Average Number of steps per 24 h

    Measured: 24 months

  27. Physical activity - PAM - Times out of bed

    Number of Times out of bed

    Measured: 24 months

  28. Swallow quality

    MD Anderson Dysphagia Inventory (MDADI) patient questionnaire - total score between 20 and 100, higher score indicates better day-to-day functioning

    Measured: 24 months

  29. Sleep quality

    Pittsburgh Sleep Quality Index (PSQI) patient questionnaire - score between 0 and 21; higher score indicates worse sleep quality

    Measured: 24 months

  30. 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

    Measured: 24 months

  31. 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

    Measured: 24 months

  32. Symptoms

    Symptom form - Log of symptoms and symptom severity during visits, descriptive evaluation

    Measured: 24 months

  33. Symptoms and Patient Observations

    Weekly Journal - Log of symptoms, symptom severity, and device use at home, descriptive evaluation

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start27 Jul 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06007170
Sponsor's protocol ID
ULP_2022CIP001
Other IDs
DRKS00032341, CIV-23-01-042029
Status last verified
Nov 2025
First submitted
31 Jul 2023
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SPIRION Laryngeal Pacemaker System Implantation and follow-up in people with Bilateral Vocal Cord Paralysis, run by MED-EL Elektromedizinische Geräte GmbH at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device Safety (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06007170.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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