Bilateral Vocal Cord Paralysis Clinical Trial
Official title:
Unilateral Implantation of the SPIRION Laryngeal Pacemaker in Patients With Previous Permanent Glottal Enlargement
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.
This clinical investigation aims to assess the long-term safety and performance of the SPIRION Laryngeal Pacemaker. The SPIRION Laryngeal Pacemaker is a new active implantable medical device designed and developed by MED-EL Elektromedizinische Geräte GmbH. It is currently in its pre-market approval phase and the results of this clinical investigation will be used to apply for EU market entry. The SPIRION Laryngeal Pacemaker is intended to improve the symptoms of Bilateral Vocal Fold Paralysis (BVFP) patients with respiratory symptoms severe enough to require surgical treatment. The SPIRION Laryngeal Pacemaker consists of 2 implantable (the SPIRION Electrode and the SPIRION Implant) and 1 external (the SPIRION Processor) components. The SPIRION Electrodes and the SPIRION Implant are placed subcutaneously in the neck and above the sternum, respectively. The SPIRION Processor is placed on the skin above the sternum. The external SPIRION Processor transmits the stimulation parameters to the SPIRION Implant, which in turn transmits the stimulation via the SPIRION Electrode to the posterior cricoarytenoid muscle (PCA). The PCA stimulation induces the lateralization (abduction) of the respective vocal fold (VF) and thus increases the glottal gap and improves respiratory patency. Each patient is foreseen to actively participate in this clinical investigation for a maximum of 28 months. Patients will be offered participation by their ear, nose, and throat specialist. In case a patient is interested, a thorough Informed consent process will be initiated. Patients will be tested for eligibility and if they pass, the baseline values regarding respiration, voice, and other symptoms will be recorded. A few days to weeks later, the SPIRION Laryngeal Pacemaker is implanted. The Implant is activated about 2 to 4 weeks after a successful implantation and is fitted to the individual needs of the patient. Subsequent follow-up (FU) visits are conducted after about 1, 3, 6, 9, 12, 18, and 24 months after the activation of the device. The results of the various tests meant to assesses the patients' quality of respiration, voice, and other symptoms are recorded. The SPIRION Laryngeal Pacemaker will be transiently deactivated twice between 12 and 24 months after activation. Tests will be performed in this period and compared with the previous and subsequent tests performed with the active device. In addition, patients' activity before implantation and during the 24-month FU period will be regularly assessed. Upon study conclusion, the patients will be actively followed-up every 6 months until the SPIRION Laryngeal Pacemaker receives a CE certification, or it is surgically removed. The implantation of the SPIRION Laryngeal Pacemaker should generally improve the BVFP symptoms of patients regarding respiration, swallowing, and sleep quality. Voice quality should not be affected or even improve. Moderate physical activity (e.g., using an E-bike) should become possible, leading to an improved general quality of life. Unlike surgical glottal enlargement, the implantation of the SPIRION Laryngeal Pacemaker should not lead to problems with swallowing and aspiration. In addition, it should lead to a lesser rate and /or severity of surgical complications and surgery-related side-effects. ;
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