Unilateral Implantation of the SPIRION Laryngeal Pacemaker in Patients Without Previous Permanent Glottal Enlargement
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bilateral Vocal Cord Paralysis
- Sponsor
- MED-EL Elektromedizinische Geräte GesmbH
- Enrollment
- 20
- Locations
- 6
- Primary Endpoint
- Device Safety
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief 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.
Detailed Description
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 Electrode and the SPIRION Implant are placed below the skin 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 3 to 5 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.
Investigators
Eligibility Criteria
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
- •With sufficient autonomous respiratory capacity to maintain their vital functions independently 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
- •At least one PCA 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 an ongoing or chronic laryngeal inflammation at the time of enrolment
- •Vocal fold immobility caused by arytenoid joint dysfunctions (e.g., arthritis, scarring, etc.), malignancies, central nervous system (CNS) pathologies, and/or systemic diseases
- •Patients who underwent previous permanent surgical glottal enlargement
- •Patients who underwent any other laryngeal surgeries (e.g., laryngeal framework surgery) that would compromise the correct SPIRION Electrode placement and/or the intended functionality of the SPIRION Laryngeal Pacemaker
- •The adductor laryngeal muscles on either or both sides underwent a botulinum toxin injection that is still effective at the time of surgery (i.e., the respective VF position is either in intermediate or lateral position)
- •Patients who underwent thoracic surgeries that would compromise at least one of the following procedures:
- •Correct placement of the SPIRION Electrode or SPIRION Implant
- •Connection of the SPIRION Implant with the SPIRION Electrode
Outcomes
Primary Outcomes
Device Safety
Time Frame: 12 Months
Number of Adverse Events (AEs), Serious Adverse Device Effect (SADEs), and Device Deficiencies (DDs)
Device Performance - Respiration
Time Frame: 12 months
PIF (Peak Inspiratory Flow) \[L/min\]
Secondary Outcomes
- Voice Quality - Fundamental Frequency (F0)(24 months)
- Voice Quality - Sound Pressure Level (SPL)(24 months)
- Voice Quality - Roughness, Breathiness, Hoarseness (RBH)(24 months)
- Voice Quality - Voice Handicap Index (VHI)-9(24 months)
- Respiratory patency - Absolute Vital Capacity (VC)(24 months)
- Respiratory patency - Normalized VC(24 months)
- Respiratory patency - Absolute Forced Expiratory Volume in one second (FEV1)(24 months)
- Respiratory patency - Absolute Forced Vital Capacity (FVC)(24 months)
- Respiratory patency - Phonation quotient (PQ)(24 months)
- Respiratory patency - Estimated Mean Flow Rate (EMFR)(24 months)
- Voice Quality - Maximum Phonation Time (MPT)(24 months)
- Voice Quality - Jitter(24 months)
- Voice Quality - Dysphonia Severity Index (DSI)(24 months)
- Respiratory patency - Absolute Peak Expiratory Flow (PEF)(24 months)
- Respiratory patency - Normalized PEF(24 months)
- Respiratory patency - Normalized FEV1(24 months)
- Physical activity - PAM - Times out of bed(24 months)
- Respiratory patency - Absolute Peak Inspiratory Flow (PIF)(24 months)
- Respiratory patency - Normalized FVC(24 months)
- Respiratory patency - Tiffeneau Index(24 months)
- Respiratory patency - St. George's Respiratory Questionnaire (SGRQ)(24 months)
- Respiratory patency - Normalized PIF(24 months)
- Physical activity - 6 Minute Walk Test (6MWT)(24 months)
- Physical activity - Physical Activity Monitor (PAM) - Physical activity level (PAL)(24 months)
- Physical activity - PAM - Activity/Rest durations(24 months)
- Physical activity - PAM - Movement intensity(24 months)
- Physical activity - PAM - Number of steps(24 months)
- Swallow quality(24 months)
- Sleep quality(24 months)
- Participant's Quality of Life - Short Form-36 (SF-36) questionnaire(24 months)
- Participant's Quality of Life - Glasgow Benefit Inventory (GBI)(24 months)
- Symptoms(24 months)
- Symptoms and Patient Observations(24 months)