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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v4
  2. Study description revised
    • Eligibility criteria shortened, about 3 words
    v3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06007170
Lead Sponsor MED-EL Elektromedizinische Geräte GesmbH
Conditions
(from sponsor)		 Bilateral Vocal Cord Paralysis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov