xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06007170</url>
    </required_header>
    <id_info>
      <org_study_id>ULP_2022CIP001</org_study_id>
      <secondary_id>DRKS00032341</secondary_id>
      <secondary_id>CIV-23-01-042029</secondary_id>
      <nct_id>NCT06007170</nct_id>
    </id_info>
    <brief_title>Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement</brief_title>
    <official_title>Unilateral Implantation of the SPIRION Laryngeal Pacemaker in Patients Without Previous Permanent Glottal Enlargement</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>MED-EL Elektromedizinische Geräte GesmbH</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>MED-EL Elektromedizinische Geräte GesmbH</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical investigation is to learn about the use of a novel medical device,&#xD;
        the SPIRION Laryngeal Pacemaker, in patients suffering from bilateral vocal fold paralysis&#xD;
        (BVFP). The main questions it aims to answer are:&#xD;
  &#xD;
          -  Is the use of the device safe?&#xD;
  &#xD;
          -  Does the device improve the participants ability to take a breath?&#xD;
  &#xD;
        Participants will be implanted with the SPIRION Laryngeal Pacemaker and the development of&#xD;
        their symptoms will be observed for the following 2 years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This clinical investigation aims to assess the long-term safety and performance of the&#xD;
        SPIRION Laryngeal Pacemaker. The SPIRION Laryngeal Pacemaker is a new active implantable&#xD;
        medical device designed and developed by MED-EL Elektromedizinische Geräte GmbH. It is&#xD;
        currently in its pre-market approval phase and the results of this clinical investigation&#xD;
        will be used to apply for EU market entry.&#xD;
  &#xD;
        The SPIRION Laryngeal Pacemaker is intended to improve the symptoms of Bilateral Vocal Fold&#xD;
        Paralysis (BVFP) patients with respiratory symptoms severe enough to require surgical&#xD;
        treatment.&#xD;
  &#xD;
        The SPIRION Laryngeal Pacemaker consists of 2 implantable (the SPIRION Electrode and the&#xD;
        SPIRION Implant) and 1 external (the SPIRION Processor) components. The SPIRION Electrodes&#xD;
        and the SPIRION Implant are placed below the skin in the neck and above the sternum,&#xD;
        respectively. The SPIRION Processor is placed on the skin above the sternum.&#xD;
  &#xD;
        The external SPIRION Processor transmits the stimulation parameters to the SPIRION Implant,&#xD;
        which in turn transmits the stimulation via the SPIRION Electrode to the posterior&#xD;
        cricoarytenoid muscle (PCA). The PCA stimulation induces the lateralization (abduction) of&#xD;
        the respective vocal fold (VF) and thus increases the glottal gap and improves respiratory&#xD;
        patency.&#xD;
  &#xD;
        Each patient is foreseen to actively participate in this clinical investigation for a maximum&#xD;
        of 28 months. Patients will be offered participation by their ear, nose, and throat&#xD;
        specialist. In case a patient is interested, a thorough Informed consent process will be&#xD;
        initiated. Patients will be tested for eligibility and if they pass, the baseline values&#xD;
        regarding respiration, voice and other symptoms will be recorded. A few days to weeks later,&#xD;
        the SPIRION Laryngeal Pacemaker is implanted. The Implant is activated about 2 to 4 weeks&#xD;
        after a successful implantation and is fitted to the individual needs of the patient.&#xD;
        Subsequent follow-up (FU) visits are conducted after about 1, 3, 6, 9, 12, 18, and 24 months&#xD;
        after the activation of the device. The results of the various tests meant to assesses the&#xD;
        patients' quality of respiration, voice, and other symptoms are recorded. The SPIRION&#xD;
        Laryngeal Pacemaker will be transiently deactivated twice between 12 and 24 months after&#xD;
        activation. Tests will be performed in this period and compared with the previous and&#xD;
        subsequent tests performed with the active device. In addition, patients' activity before&#xD;
        implantation and during the 24-month FU period will be regularly assessed. Upon study&#xD;
        conclusion, the patients will be actively followed-up every 6 months until the SPIRION&#xD;
        Laryngeal Pacemaker receives a CE certification, or it is surgically removed.&#xD;
  &#xD;
        The implantation of the SPIRION Laryngeal Pacemaker should generally improve the BVFP&#xD;
        symptoms of patients regarding respiration, swallowing, and sleep quality. Voice quality&#xD;
        should not be affected or even improve. Moderate physical activity (e.g., using an E-bike)&#xD;
        should become possible, leading to an improved general quality of life.&#xD;
  &#xD;
        Unlike surgical glottal enlargement, the implantation of the SPIRION Laryngeal Pacemaker&#xD;
        should not lead to problems with swallowing and aspiration. In addition, it should lead to a&#xD;
        lesser rate and /or severity of surgical complications and surgery-related side-effects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 27, 2023</start_date>
    <completion_date type="Anticipated">December 2028</completion_date>
    <primary_completion_date type="Anticipated">December 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Device Safety</measure>
      <time_frame>12 Months</time_frame>
      <description>Number of Adverse Events (AEs), Serious Adverse Device Effect (SADEs), and Device Deficiencies (DDs)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Device Performance - Respiration</measure>
      <time_frame>12 months</time_frame>
      <description>PIF (Peak Inspiratory Flow) [L/min]</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Voice Quality - Fundamental Frequency (F0)</measure>
      <time_frame>24 months</time_frame>
      <description>F0 range [Hz]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Voice Quality - Sound Pressure Level (SPL)</measure>
      <time_frame>24 months</time_frame>
      <description>SPL range [dB]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Voice Quality - Maximum Phonation Time (MPT)</measure>
      <time_frame>24 months</time_frame>
      <description>MPT [s]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Voice Quality - Jitter</measure>
      <time_frame>24 months</time_frame>
      <description>Jitter in percentage [%]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Voice Quality - Roughness, Breathiness, Hoarseness (RBH)</measure>
      <time_frame>24 months</time_frame>
      <description>RBH - score between 0 and 3 for each characteristic, higher score indicates worse voice quality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Voice Quality - Dysphonia Severity Index (DSI)</measure>
      <time_frame>24 months</time_frame>
      <description>DSI - calculated as 0,13 * MPT + 0,0053 * F0_maximal - 0,26 * SPL_minimal - 1,18 * Jitter + 12,4; the following ranges apply: abnormal voice (-5 &lt; X ≤ 1,6); normal voice (1,6 &lt; X ≤ 5), not evaluable (≤ -5)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Voice Quality - Voice Handicap Index (VHI)-9</measure>
      <time_frame>24 months</time_frame>
      <description>VHI-9 patient questionnaire - score between 0 and 36, higher score indicates worse voice quality)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - Absolute Peak Expiratory Flow (PEF)</measure>
      <time_frame>24 months</time_frame>
      <description>Absolute PEF [L/min]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - Normalized PEF</measure>
      <time_frame>24 months</time_frame>
      <description>Normalized PEF [L/min]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - Absolute Peak Inspiratory Flow (PIF)</measure>
      <time_frame>24 months</time_frame>
      <description>Absolute PIF [L/min]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - Normalized PIF</measure>
      <time_frame>24 months</time_frame>
      <description>Normalized PIF [L/min]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - Absolute Vital Capacity (VC)</measure>
      <time_frame>24 months</time_frame>
      <description>Absolute VC [L]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - Normalized VC</measure>
      <time_frame>24 months</time_frame>
      <description>Normalized VC [L]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - Absolute Forced Expiratory Volume in one second (FEV1)</measure>
      <time_frame>24 months</time_frame>
      <description>Absolute FEV1 [L]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - Normalized FEV1</measure>
      <time_frame>24 months</time_frame>
      <description>Normalized FEV1 [L]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - Absolute Forced Vital Capacity (FVC)</measure>
      <time_frame>24 months</time_frame>
      <description>Absolute FVC [L]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - Normalized FVC</measure>
      <time_frame>24 months</time_frame>
      <description>Normalized FVC [L]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - Tiffeneau Index</measure>
      <time_frame>24 months</time_frame>
      <description>Tiffeneau Index - calculated as (FEV1/FVC)*100</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - Phonation quotient (PQ)</measure>
      <time_frame>24 months</time_frame>
      <description>PQ - calculated as VC/MPT [L/s]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - Estimated Mean Flow Rate (EMFR)</measure>
      <time_frame>24 months</time_frame>
      <description>EMFR - calculated as 77+0.236*PQ</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory patency - St. George's Respiratory Questionnaire (SGRQ)</measure>
      <time_frame>24 months</time_frame>
      <description>SGRQ patient questionnaire - score between 0 and 100; higher score indicates worse health</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity - 6 Minute Walk Test (6MWT)</measure>
      <time_frame>24 months</time_frame>
      <description>6MWT [m]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity - Physical Activity Monitor (PAM) - Physical activity level (PAL)</measure>
      <time_frame>24 months</time_frame>
      <description>PAL - calculated as Total Energy Expenditure [Kcal]/Basal Metabolic Rate[Kcal]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity - PAM - Activity/Rest durations</measure>
      <time_frame>24 months</time_frame>
      <description>Durations of activity/inactivity/sleep measured in [h:m] and [%]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity - PAM - Movement intensity</measure>
      <time_frame>24 months</time_frame>
      <description>Movement intensity [g]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity - PAM - Number of steps</measure>
      <time_frame>24 months</time_frame>
      <description>Average Number of steps per 24 h</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity - PAM - Times out of bed</measure>
      <time_frame>24 months</time_frame>
      <description>Number of Times out of bed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Swallow quality</measure>
      <time_frame>24 months</time_frame>
      <description>MD Anderson Dysphagia Inventory (MDADI) patient questionnaire - total score between 20 and 100, higher score indicates better day-to-day functioning</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep quality</measure>
      <time_frame>24 months</time_frame>
      <description>Pittsburgh Sleep Quality Index (PSQI) patient questionnaire - score between 0 and 21; higher score indicates worse sleep quality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant's Quality of Life - Short Form-36 (SF-36) questionnaire</measure>
      <time_frame>24 months</time_frame>
      <description>SF-36 patient questionnaire - score between 0 and 100, higher score indicates better health</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant's Quality of Life - Glasgow Benefit Inventory (GBI)</measure>
      <time_frame>24 months</time_frame>
      <description>GBI patient questionnaire - score between -100 and 100, negative scores indicate a poor outcome, positive scores indicate a good outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptoms</measure>
      <time_frame>24 months</time_frame>
      <description>Symptom form - Log of symptoms and symptom severity during visits, descriptive evaluation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptoms and Patient Observations</measure>
      <time_frame>24 months</time_frame>
      <description>Weekly Journal - Log of symptoms, symptom severity, and device use at home, descriptive evaluation</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Bilateral Vocal Cord Paralysis</condition>
    <arm_group>
      <arm_group_label>Treatment Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SPIRION Laryngeal Pacemaker System Implantation and follow-up</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SPIRION Laryngeal Pacemaker System Implantation and follow-up</intervention_name>
      <description>Timeline of Visits&#xD;
  Screening&#xD;
  Baseline: Official baseline, assessment primary &amp; secondary objectives&#xD;
  Implantation of device&#xD;
  Activation &amp; fitting: Baseline active device; implanted device has just been activated; assessment of secondary objectives only&#xD;
  8 FU Visits over 2 years after activation; Includes&#xD;
  Baseline Switch Off: results of the visit preceding a 14-day switch-off of the device; assessment of secondary objectives only&#xD;
  Endpoints for&#xD;
  Pivotal phase: 12 months after activation; official endpoint for assessment of primary &amp; secondary objectives&#xD;
  Active post-pivotal phase: 24-month follow-up; endpoint for all secondary objectives&#xD;
  Switch Off: 2 Visits; assessment of secondary objectives only&#xD;
  Repeated checkpoints to assess device effects over 2 years: 5 visits; assessment of secondary objectives only Device shall increase respiratory patency during inspiration, assessed by normalized PIF; other outcome measures are used to assess secondary objectives</description>
      <arm_group_label>Treatment Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          General information&#xD;
  &#xD;
          The following patient categories can be recruited into this clinical investigation if they&#xD;
          comply with all the selection criteria:&#xD;
  &#xD;
            -  Patients recruited in the previous first-in-human (FIH) clinical investigation&#xD;
               2011CIP001&#xD;
  &#xD;
            -  Patients with an open tracheostoma at the time of enrolment&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Between 18 and 75 years old at the time of enrolment (i.e., informed consent form&#xD;
               (ICF) signed)&#xD;
  &#xD;
            -  Diagnosed with BVFP for a minimum of 6 months&#xD;
  &#xD;
            -  With sufficient autonomous respiratory capacity to maintain their vital functions&#xD;
               independently of the SPIRION Laryngeal Pacemaker. Before a permanent closure of the&#xD;
               tracheostomy is carried out during this clinical investigation, the Principal&#xD;
               Investigator shall confirm that at least at rest, the failure of the SPIRION Laryngeal&#xD;
               Pacemaker would not put the patient in a life-threatening condition because of&#xD;
               insufficient respiratory patency&#xD;
  &#xD;
            -  At least one PCA responds to electrical stimulation (clear abduction of the respective&#xD;
               VF in response to electrical stimulation) within an Endoscopic Cap Electrode (ECE50)&#xD;
               test, or shows reinnervation in an laryngeal electromyography (LEMG) assessment&#xD;
  &#xD;
            -  Fluent in German.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lack of compliance with any inclusion criteria&#xD;
  &#xD;
            -  Pregnant or breast-feeding women&#xD;
  &#xD;
            -  Patients suffering from an ongoing or chronic laryngeal inflammation at the time of&#xD;
               enrolment&#xD;
  &#xD;
            -  Vocal fold immobility caused by arytenoid joint dysfunctions (e.g., arthritis,&#xD;
               scarring, etc.), malignancies, central nervous system (CNS) pathologies, and/or&#xD;
               systemic diseases&#xD;
  &#xD;
            -  Patients who underwent previous permanent surgical glottal enlargement&#xD;
  &#xD;
            -  Patients who underwent any other laryngeal surgeries (e.g., laryngeal framework&#xD;
               surgery) that would compromise the correct SPIRION Electrode placement and/or the&#xD;
               intended functionality of the SPIRION Laryngeal Pacemaker&#xD;
  &#xD;
            -  The adductor laryngeal muscles on either or both sides underwent a botulinum toxin&#xD;
               injection that is still effective at the time of surgery (i.e., the respective VF&#xD;
               position is either in intermediate or lateral position)&#xD;
  &#xD;
            -  Patients who underwent thoracic surgeries that would compromise at least one of the&#xD;
               following procedures:&#xD;
  &#xD;
            -  Correct placement of the SPIRION Electrode or SPIRION Implant&#xD;
  &#xD;
            -  Connection of the SPIRION Implant with the SPIRION Electrode&#xD;
  &#xD;
            -  Connection of the SPIRION Implant with the external SPIRION Processor&#xD;
  &#xD;
            -  Patients wearing an active implantable medical device at the time of enrolment&#xD;
  &#xD;
            -  Patients with a clinical history that would suggest a high probability that they would&#xD;
               need an MRI&#xD;
  &#xD;
            -  Patients diagnosed with a malignant disease in the head and neck region&#xD;
  &#xD;
            -  Patients diagnosed with chronic airway infections or obstructions, or severe&#xD;
               respiratory diseases (e.g., chronic obstructive pulmonary disease (COPD) grade II or&#xD;
               higher)&#xD;
  &#xD;
            -  Patients who underwent external beam radiation therapy in the surgical area&#xD;
  &#xD;
            -  Patients diagnosed with a serious coagulation disorder requiring an uninterruptable&#xD;
               use of anticoagulants&#xD;
  &#xD;
            -  Patients with known allergies to the SPIRION Laryngeal Pacemaker material in direct&#xD;
               contact with the human body&#xD;
  &#xD;
            -  Patients suffering from severe depression or any other psychological or psychiatric&#xD;
               disease&#xD;
  &#xD;
            -  Any anatomic, physiological, or medical conditions that may increase the risks linked&#xD;
               to the SPIRION Laryngeal Pacemaker implantation and/or reduce its benefit for the&#xD;
               patient&#xD;
  &#xD;
            -  Parallel participation in a device/drug clinical investigation in the period of data&#xD;
               collection, which could confound the results of this clinical investigation&#xD;
  &#xD;
            -  Anything that, in the opinion of the Principal Investigator, would place the patient&#xD;
               at increased risk or preclude the patient's full compliance with the general&#xD;
               requirements of this clinical investigation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Andreas Müller, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>SRH Wald-Klinikum Gera GmbH</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Berit Schneider-Stickler, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medical University of Vienna</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Dirk Mürbe, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Charité - Medical University of Berlin</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Claus Potoschnig, Univ-Doz.Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tirol Kiniken GmbH</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jan-Constantin Kölmel, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stuttgart Hospital - Katharinenhospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Rudolf Hagen, Prof. Dr.Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Würzburg</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pia Plattner, MSc.</last_name>
      <phone>+43664607051681</phone>
      <email>pia.plattner@medel.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Cristina Rubiolo, PhD</last_name>
      <phone>+43664607055556</phone>
      <email>cristina.rubiolo@medel.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tirol Kliniken GmbH</name>
        <address>
          <city>Innsbruck</city>
          <state>Tirol</state>
          <zip>6020</zip>
          <country>Austria</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Claus Potoschnig, Univ-Doz.Dr.</last_name>
        <phone>+43 512 504 81876</phone>
        <email>claus.pototschnig@tirol-kliniken.at</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Medical University of Vienna</name>
        <address>
          <city>Vienna</city>
          <zip>1090</zip>
          <country>Austria</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Berit Schneider-Stickler, Prof. Dr.</last_name>
        <phone>+43 140 400 33100</phone>
        <email>berit.schneider-stickler@meduniwien.ac</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Stuttgart Hospital - Katharinenhospital</name>
        <address>
          <city>Stuttgart</city>
          <state>Baden-Württemberg</state>
          <zip>70174</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jan-Constantin Kölmel, Dr.</last_name>
        <phone>+49 711 278 33270</phone>
        <email>c.koelmel@klinikum-stuttgart.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Hospital of Würzburg</name>
        <address>
          <city>Würzburg</city>
          <state>Bavaria</state>
          <zip>97080</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rudolf Hagen, Prof. Dr.Dr.</last_name>
        <phone>+49 931 201 21701</phone>
        <email>hagen_r@ukw.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>SRH Wald-Klinikum Gera GmbH</name>
        <address>
          <city>Gera</city>
          <state>Thüringen</state>
          <zip>07548</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andreas Müller, Prof. Dr.</last_name>
        <phone>+49 365 828 2650</phone>
        <email>andreas.mueller@srh.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Charité - Medical University of Berlin</name>
        <address>
          <city>Berlin</city>
          <zip>10117</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dirk Mürbe, Prof. Dr.</last_name>
        <phone>+49 30 450 555 402</phone>
        <email>dirk.muerbe@charite.de</email>
      </contact>
    </location>
    <location_countries>
      <country>Austria</country>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Bilateral Vocal Fold Paralysis</keyword>
    <keyword>BVFP</keyword>
    <keyword>Bilateral Vocal Cord Paralysis</keyword>
    <keyword>BVCP</keyword>
    <keyword>Laryngeal Pacemaker</keyword>
    <keyword>Electrical Stimulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vocal Cord Paralysis</mesh_term>
      <mesh_term>Paralysis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06007170
  org study id: ULP_2022CIP001
  secondary id: DRKS00032341
  secondary id: CIV-23-01-042029
  nct id: NCT06007170
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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 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 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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Device Safety
  time frame: 12 Months
  description: Number of Adverse Events (AEs), Serious Adverse Device Effect (SADEs), and Device Deficiencies (DDs)
  measure: Device Performance - Respiration
  time frame: 12 months
  description: PIF (Peak Inspiratory Flow) [L/min]
  measure: Voice Quality - Fundamental Frequency (F0)
  time frame: 24 months
  description: F0 range [Hz]
  measure: Voice Quality - Sound Pressure Level (SPL)
  time frame: 24 months
  description: SPL range [dB]
  measure: Voice Quality - Maximum Phonation Time (MPT)
  time frame: 24 months
  description: MPT [s]
  measure: Voice Quality - Jitter
  time frame: 24 months
  description: Jitter in percentage [%]
  measure: Voice Quality - Roughness, Breathiness, Hoarseness (RBH)
  time frame: 24 months
  description: RBH - score between 0 and 3 for each characteristic, higher score indicates worse voice quality
  measure: Voice Quality - Dysphonia Severity Index (DSI)
  time frame: 24 months
  description: DSI - calculated as 0,13 * MPT + 0,0053 * F0_maximal - 0,26 * SPL_minimal - 1,18 * Jitter + 12,4; the following ranges apply: abnormal voice (-5 < X ≤ 1,6); normal voice (1,6 < X ≤ 5), not evaluable (≤ -5)
  measure: Voice Quality - Voice Handicap Index (VHI)-9
  time frame: 24 months
  description: VHI-9 patient questionnaire - score between 0 and 36, higher score indicates worse voice quality)
  measure: Respiratory patency - Absolute Peak Expiratory Flow (PEF)
  time frame: 24 months
  description: Absolute PEF [L/min]
  measure: Respiratory patency - Normalized PEF
  time frame: 24 months
  description: Normalized PEF [L/min]
  measure: Respiratory patency - Absolute Peak Inspiratory Flow (PIF)
  time frame: 24 months
  description: Absolute PIF [L/min]
  measure: Respiratory patency - Normalized PIF
  time frame: 24 months
  description: Normalized PIF [L/min]
  measure: Respiratory patency - Absolute Vital Capacity (VC)
  time frame: 24 months
  description: Absolute VC [L]
  measure: Respiratory patency - Normalized VC
  time frame: 24 months
  description: Normalized VC [L]
  measure: Respiratory patency - Absolute Forced Expiratory Volume in one second (FEV1)
  time frame: 24 months
  description: Absolute FEV1 [L]
  measure: Respiratory patency - Normalized FEV1
  time frame: 24 months
  description: Normalized FEV1 [L]
  measure: Respiratory patency - Absolute Forced Vital Capacity (FVC)
  time frame: 24 months
  description: Absolute FVC [L]
  measure: Respiratory patency - Normalized FVC
  time frame: 24 months
  description: Normalized FVC [L]
  measure: Respiratory patency - Tiffeneau Index
  time frame: 24 months
  description: Tiffeneau Index - calculated as (FEV1/FVC)*100
  measure: Respiratory patency - Phonation quotient (PQ)
  time frame: 24 months
  description: PQ - calculated as VC/MPT [L/s]
  measure: Respiratory patency - Estimated Mean Flow Rate (EMFR)
  time frame: 24 months
  description: EMFR - calculated as 77+0.236*PQ
  measure: Respiratory patency - St. George's Respiratory Questionnaire (SGRQ)
  time frame: 24 months
  description: SGRQ patient questionnaire - score between 0 and 100; higher score indicates worse health
  measure: Physical activity - 6 Minute Walk Test (6MWT)
  time frame: 24 months
  description: 6MWT [m]
  measure: Physical activity - Physical Activity Monitor (PAM) - Physical activity level (PAL)
  time frame: 24 months
  description: PAL - calculated as Total Energy Expenditure [Kcal]/Basal Metabolic Rate[Kcal]
  measure: Physical activity - PAM - Activity/Rest durations
  time frame: 24 months
  description: Durations of activity/inactivity/sleep measured in [h:m] and [%]
  measure: Physical activity - PAM - Movement intensity
  time frame: 24 months
  description: Movement intensity [g]
  measure: Physical activity - PAM - Number of steps
  time frame: 24 months
  description: Average Number of steps per 24 h
  measure: Physical activity - PAM - Times out of bed
  time frame: 24 months
  description: Number of Times out of bed
  measure: Swallow quality
  time frame: 24 months
  description: MD Anderson Dysphagia Inventory (MDADI) patient questionnaire - total score between 20 and 100, higher score indicates better day-to-day functioning
  measure: Sleep quality
  time frame: 24 months
  description: Pittsburgh Sleep Quality Index (PSQI) patient questionnaire - score between 0 and 21; higher score indicates worse sleep quality
  measure: Participant's Quality of Life - Short Form-36 (SF-36) questionnaire
  time frame: 24 months
  description: SF-36 patient questionnaire - score between 0 and 100, higher score indicates better health
  measure: Participant's Quality of Life - Glasgow Benefit Inventory (GBI)
  time frame: 24 months
  description: GBI patient questionnaire - score between -100 and 100, negative scores indicate a poor outcome, positive scores indicate a good outcome
  measure: Symptoms
  time frame: 24 months
  description: Symptom form - Log of symptoms and symptom severity during visits, descriptive evaluation
  measure: Symptoms and Patient Observations
  time frame: 24 months
  description: Weekly Journal - Log of symptoms, symptom severity, and device use at home, descriptive evaluation
  arm group label: Treatment Group
  arm group type: Experimental
  description: SPIRION Laryngeal Pacemaker System Implantation and follow-up
  intervention type: Device
  intervention name: SPIRION Laryngeal Pacemaker System Implantation and follow-up
  description: Timeline of Visits
  Screening
  Baseline: Official baseline, assessment primary & secondary objectives
  Implantation of device
  Activation & fitting: Baseline active device; implanted device has just been activated; assessment of secondary objectives only
  8 FU Visits over 2 years after activation; Includes
  Baseline Switch Off: results of the visit preceding a 14-day switch-off of the device; assessment of secondary objectives only
  Endpoints for
  Pivotal phase: 12 months after activation; official endpoint for assessment of primary & secondary objectives
  Active post-pivotal phase: 24-month follow-up; endpoint for all secondary objectives
  Switch Off: 2 Visits; assessment of secondary objectives only
  Repeated checkpoints to assess device effects over 2 years: 5 visits; assessment of secondary objectives only Device shall increase respiratory patency during inspiration, assessed by normalized PIF; other outcome measures are used to assess secondary objectives
  arm group label: Treatment Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Andreas Müller, Prof. Dr.
  role: Principal Investigator
  affiliation: SRH Wald-Klinikum Gera GmbH
  last name: Berit Schneider-Stickler, Prof. Dr.
  role: Principal Investigator
  affiliation: Medical University of Vienna
  last name: Dirk Mürbe, Prof. Dr.
  role: Principal Investigator
  affiliation: Charité - Medical University of Berlin
  last name: Claus Potoschnig, Univ-Doz.Dr.
  role: Principal Investigator
  affiliation: Tirol Kiniken GmbH
  last name: Jan-Constantin Kölmel, Dr.
  role: Principal Investigator
  affiliation: Stuttgart Hospital - Katharinenhospital
  last name: Rudolf Hagen, Prof. Dr.Dr.
  role: Principal Investigator
  affiliation: University Hospital of Würzburg
  last name: Pia Plattner, MSc.
  phone: +43664607051681
  email: pia.plattner@medel.com
  last name: Cristina Rubiolo, PhD
  phone: +43664607055556
  email: cristina.rubiolo@medel.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Austria
  country: Germany
  responsible party type: Sponsor
  mesh term: Vocal Cord Paralysis
  mesh term: Paralysis
  sharing ipd: No