Clinical Trial

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

Active, Not Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-08-17; most recent amendment 2025-11-19.
Status change: Recruiting → Active, Not Recruiting 2025-11-19
Trial Details
NCT Number NCT06007170
Lead Sponsor MED-EL Elektromedizinische Geräte GesmbH
Conditions Bilateral Vocal Cord Paralysis
Enrollment 20 participants
Start Date 2023-07-27
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-20