Using a new laryngeal pacemaker for patients with bilateral vocal fold paralysis
Unilateral Implantation of the SPIRION Laryngeal Pacemaker in Patients With Previous Permanent Glottal Enlargement
This study is testing a new laryngeal pacemaker to see if it can help people with bilateral vocal fold paralysis breathe better after they've had surgery for their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | MED-EL Elektromedizinische Geräte GesmbH Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 6 sites (Innsbruck, Tirol and 5 other locations) |
| Trial ID | NCT06007144 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the safety and effectiveness of the SPIRION Laryngeal Pacemaker in patients suffering from bilateral vocal fold paralysis (BVFP) who have undergone at least one surgery related to their condition. Participants will receive the device, which consists of implantable and external components, and their respiratory function will be monitored over a period of up to 28 months. The study aims to determine if the device can improve breathing by stimulating the muscles that control vocal fold movement. Results from this investigation will support the application for EU market entry of the device.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 diagnosed with BVFP for at least 6 months who have had prior surgical interventions.
Not a fit: Patients who do not have sufficient respiratory capacity or have not undergone the required surgical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve breathing and quality of life for patients with BVFP.
How similar studies have performed: While this approach is novel, previous studies on laryngeal stimulation devices have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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 first-in-human (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., informed consent form (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 Endoscopic Cap Electrode (ECE50) test * 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, central nervous system (CNS) pathologies, and/or systemic diseases * Patients who underwent previous bilateral permanent surgical glottal enlargement * Patients who never underwent a permanent glottal enlargement on either vocal fold * 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., 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 Depression Inventory II (BDI-II) ≥ 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.
Where this trial is running
Innsbruck, Tirol and 5 other locations
- Tirol Kliniken GmbH — Innsbruck, Tirol, Austria (Recruiting)
- Medical University of Vienna — Vienna, Austria (Recruiting)
- Stuttgart Hospital - Katharinenhospital — Stuttgart, Baden-Württemberg, Germany (Recruiting)
- University Hospital of Würzburg — Würzburg, Bavaria, Germany (Recruiting)
- SRH Wald-Klinikum Gera GmbH — Gera, Thüringen, Germany (Recruiting)
- Charité - Medical University of Berlin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Andreas Müller, Prof. Dr. — SRH Wald-Klinikum Gera GmbH
- Study coordinator: Pia Plattner, MSc.
- Email: pia.plattner@medel.com
- Phone: +43 664 607 051 681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.