TerminatedNot Applicable

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

Stopped: The DMC terminated trial GLP\_2022C1P002 early, citing a no longer positive benefit risk ratio, very low recruitment (\<1 patient/year/site), no added patient risk, but no relevant advantages to justify continuing the study and potential risks of TIVA.

Austria, Germany10 participantsStarted 2023-08-18

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Device Safety

Timeframe: 12 Months

Device Performance - Respiration

Timeframe: 12 Months

Trial details

NCT IDNCT06007144

SponsorMED-EL Elektromedizinische Geräte GesmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-07

View on ClinicalTrials.gov More Bilateral Vocal Cord Paralysis trials