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

NCT06007170 | Active Not Recruiting

• 3 other identifiers: ULP_2022CIP001DRKS00032341CIV-23-01-042029
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 6

Brief 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). 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.

Conditions

Bilateral Vocal Cord Paralysis

Keywords

Bilateral Vocal Fold Paralysis; BVFP; Bilateral Vocal Cord Paralysis; BVCP; Laryngeal Pacemaker; Electrical Stimulation

Outcome Measures

Primary Outcomes (2)

• Device Safety

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

  12 Months

• Device Performance - Respiration

  PIF (Peak Inspiratory Flow) \[L/min\]

  12 months

Secondary Outcomes (33)

• Voice Quality - Fundamental Frequency (F0)

  24 months

• Voice Quality - Sound Pressure Level (SPL)

  24 months

• Voice Quality - Maximum Phonation Time (MPT)

  24 months

• Voice Quality - Jitter

  24 months

• Voice Quality - Roughness, Breathiness, Hoarseness (RBH)

  24 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

SPIRION Laryngeal Pacemaker System Implantation and follow-up

Device: SPIRION Laryngeal Pacemaker System Implantation and follow-up

Interventions

SPIRION Laryngeal Pacemaker System Implantation and follow-up DEVICE

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

Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (6)

Tirol Kliniken GmbH

Innsbruck, Tyrol, 6020, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Stuttgart Hospital - Katharinenhospital

Stuttgart, Baden-Wurttemberg, 70174, Germany

Location

University Hospital of Würzburg

Würzburg, Bavaria, 97080, Germany

Location

SRH Wald-Klinikum Gera GmbH

Gera, Thuringia, 07548, Germany

Location

Charité - Medical University of Berlin

Berlin, 10117, Germany

Location

Study Officials

• Andreas Müller, Prof. Dr.

  SRH Wald-Klinikum Gera GmbH

  PRINCIPAL INVESTIGATOR

• Berit Schneider-Stickler, Prof. Dr.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

• Dirk Mürbe, Prof. Dr.

  Charité - Medical University of Berlin

  PRINCIPAL INVESTIGATOR

• Claus Potoschnig, Univ-Doz.Dr.

  Tirol Kiniken GmbH

  PRINCIPAL INVESTIGATOR

• Jan-Constantin Kölmel, Dr.

  Stuttgart Hospital - Katharinenhospital

  PRINCIPAL INVESTIGATOR

• Rudolf Hagen, Prof. Dr.Dr.

  University Hospital of Würzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 23, 2023
• Study Start: July 27, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); DE (4)