Clinical trial NCT06007144: Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients With Single-sided Glottal Enlargement
Official title: Unilateral Implantation of the SPIRION Laryngeal Pacemaker in Patients With Previous Permanent Glottal Enlargement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bilateral Vocal Cord Paralysis
Keywords: Bilateral Vocal Fold Paralysis
BVFP
Bilateral Vocal Cord Paralysis
BVCP
Laryngeal Pacemaker
Electrical Stimulation
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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) 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.

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 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.

Eligibility criteria: 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 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 bilateral permanent surgical glottal enlargement
* Patients who never underwent a permanent glottal enlargement on either vocal fold
* 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
  * Connection of the SPIRION Implant with the external SPIRION Processor
* Patients wearing an active implantable medical device at the time of enrolment
* Patients with a clinical history that would suggest a high probability that they would need an MRI
* Patients diagnosed with a malignant disease in the head and neck region
* Patients diagnosed with chronic airway infections or obstructions, or severe respiratory diseases (e.g., chronic obstructive pulmonary disease (COPD) grade II or higher)
* Patients who underwent external beam radiation therapy in the surgical area
* Patients diagnosed with a serious coagulation disorder requiring an uninterruptable use of anticoagulants
* Patients with known allergies to the SPIRION Laryngeal Pacemaker material in direct contact with the human body
* Patients suffering from moderate depression (Beck Depression Inventory II (BDI-II) ≥ 20) or any other psychological or psychiatric diseases
* Any anatomic, physiological, or medical conditions that may increase the risks linked to the SPIRION Laryngeal Pacemaker implantation and/or reduce its benefit for the patient
* Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of this clinical investigation
* Anything that, in the opinion of the Principal Investigator, would place the patient at increased risk or preclude the patient's full compliance with the general requirements of this clinical investigation.

Primary outcomes:
measure: Device Safety
timeFrame: 12 Months
measure: Device Performance - Respiration
timeFrame: 12 Months
Secondary outcomes:
measure: Voice Quality - Fundamental Frequency (F0)
timeFrame: 24 months
measure: Voice Quality - Sound Pressure Level (SPL)
timeFrame: 24 months
measure: Voice Quality - Maximum Phonation Time (MPT)
timeFrame: 24 months
measure: Voice Quality - Jitter
timeFrame: 24 months
measure: Voice Quality - Roughness, Breathiness, Hoarseness (RBH)
timeFrame: 24 months
measure: Voice Quality - Dysphonia Severity Index (DSI)
timeFrame: 24 months
measure: Voice Quality - Voice Handicap Index (VHI)-9
timeFrame: 24 months
measure: Respiratory patency - Absolute Peak Expiratory Flow (PEF)
timeFrame: 24 months
measure: Respiratory patency - Normalized PEF
timeFrame: 24 months
measure: Respiratory patency - Absolute Peak Inspiratory Flow (PIF)
timeFrame: 24 months
measure: Respiratory patency - Normalized PIF
timeFrame: 24 months
measure: Respiratory patency - Absolute Vital Capacity (VC)
timeFrame: 24 months
measure: Respiratory patency - Normalized VC
timeFrame: 24 months
measure: Respiratory patency - Absolute Forced Expiratory Volume in one second (FEV1)
timeFrame: 24 months
measure: Respiratory patency - Normalized FEV1
timeFrame: 24 months
measure: Respiratory patency - Absolute Forced Vital Capacity (FVC)
timeFrame: 24 months
measure: Respiratory patency - Normalized FVC
timeFrame: 24 months
measure: Respiratory patency - Tiffeneau Index
timeFrame: 24 months
measure: Respiratory patency - Phonation quotient (PQ)
timeFrame: 24 months
measure: Respiratory patency - Estimated Mean Flow Rate (EMFR)
timeFrame: 24 months
measure: Respiratory patency - St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 24 months
measure: Physical activity - 6 Minute Walk Test (6MWT)
timeFrame: 24 months
measure: Physical activity - Physical Activity Monitor (PAM) - Physical activity level (PAL)
timeFrame: 24 months
measure: Physical activity - PAM - Activity/Rest durations
timeFrame: 24 months
measure: Physical activity - PAM - Movement intensity
timeFrame: 24 months
measure: Physical activity - PAM - Number of steps
timeFrame: 24 months
measure: Physical activity - PAM - Times out of bed
timeFrame: 24 months
measure: Swallow quality
timeFrame: 24 months
measure: Sleep quality
timeFrame: 24 months
measure: Participant's Quality of Life - Short Form-36 (SF-36) questionnaire
timeFrame: 24 months
measure: Participant's Quality of Life - Glasgow Benefit Inventory (GBI)
timeFrame: 24 months
measure: Symptoms
timeFrame: 24 months
measure: Symptoms and Patient Observations
timeFrame: 24 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Tirol Kliniken GmbH
state: Tirol
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Stuttgart
country: Germany
facility: Stuttgart Hospital - Katharinenhospital
state: Baden-Württemberg
city: Würzburg
country: Germany
facility: University Hospital of Würzburg
state: Bavaria
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
state: Thüringen
city: Berlin
country: Germany
facility: Charité - Medical University of Berlin
Study officials:
affiliation: SRH Wald-Klinikum Gera GmbH
name: Andreas Müller, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Berit Schneider-Stickler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité - Medical University of Berlin
name: Dirk Mürbe, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tirol Kiniken GmbH
name: Claus Potoschnig, Univ-Doz.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stuttgart Hospital - Katharinenhospital
name: Jan-Constantin Kölmel, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Würzburg
name: Rudolf Hagen, Prof. Dr.Dr.
role: PRINCIPAL_INVESTIGATOR
References: