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Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients With Single-sided Glottal Enlargement

NCT06007144 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-11-24

No results posted yet for this study

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) and who have had at least one related surgery on one of their vocal folds. 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

Interventions

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

Sponsors & Collaborators

  • MED-EL Elektromedizinische Geräte GesmbH

    lead INDUSTRY

Principal Investigators

  • Andreas Müller, Prof. Dr. · SRH Wald-Klinikum Gera GmbH

  • Berit Schneider-Stickler, Prof. Dr. · Medical University of Vienna

  • Dirk Mürbe, Prof. Dr. · Charité - Medical University of Berlin

  • Claus Potoschnig, Univ-Doz.Dr. · Tirol Kiniken GmbH

  • Jan-Constantin Kölmel, Dr. · Stuttgart Hospital - Katharinenhospital

  • Rudolf Hagen, Prof. Dr.Dr. · University Hospital of Würzburg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-18
Primary Completion
2025-07-07
Completion
2025-09-16

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06007144 on ClinicalTrials.gov