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/NCT05998018</url>
    </required_header>
    <id_info>
      <org_study_id>CIP0002</org_study_id>
      <nct_id>NCT05998018</nct_id>
    </id_info>
    <brief_title>Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients</brief_title>
    <acronym>ReInvigorate</acronym>
    <official_title>Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stimdia Medical Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Stimdia Medical Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This prospective, multi-center, randomized, controlled clinical trial is being conducted to&#xD;
        evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical&#xD;
        ventilation through phrenic nerve stimulation. Potential subjects who are on mechanical&#xD;
        ventilation for at least four days and have failed at least one weaning attempt will be&#xD;
        considered for the study. Those enrolled will be randomized in a 1:1 manner between the&#xD;
        treatment group that is standard of care with the pdSTIM System and a Control group, which is&#xD;
        standard of care alone.&#xD;
  &#xD;
        The primary endpoints focus on time to weaning and serious adverse event rates between the&#xD;
        Treatment and Control groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The pdSTIM Pivotal Study (ReInvigorate Study) is a prospective, multicenter, randomized,&#xD;
        controlled clinical study to evaluate the safety and efficacy of the pdSTIM System to&#xD;
        facilitate weaning from mechanical ventilation through phrenic nerve stimulation. Potential&#xD;
        subjects who are on mechanical ventilation for ≥ 96 hours (4 days) and have failed at least&#xD;
        one weaning attempt will be considered for the study.&#xD;
  &#xD;
        Those enrolled will be randomized in a 1:1 manner between a Treatment group that is standard&#xD;
        of care with the pdSTIM System and a Control group that is standard of care only. For the&#xD;
        Treatment group, stimulation therapy with pdSTIM will occur daily until the subject is&#xD;
        successfully removed from mechanical ventilation or the 30-Day follow-up visit, whichever is&#xD;
        sooner. All randomized subjects will be followed to 60 (± 7) days post randomization. Total&#xD;
        subject participation will be no longer than 67 days.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time to Wean</measure>
      <time_frame>Following completion of the 30-day follow-up by all available randomized subjects</time_frame>
      <description>Assess time to successful weaning from mechanical ventilation for the subjects randomized to Treatment as compared to subjects randomized to Control</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of Serious Adverse Events (SAEs)</measure>
      <time_frame>Following completion of the 30-day follow-up by all available randomized subjects</time_frame>
      <description>Assessment of Serious Adverse Events (SAEs) for the subjects randomized to Treatment as compared to subjects randomized to Control</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean Change in Maximal Inspiratory Pressure (MIP)</measure>
      <time_frame>Following completion of the 30-day follow-up by all available randomized subjects</time_frame>
      <description>Assess mean change in maximal inspiratory pressure from baseline through Day 30 or at the time of successful weaning (whichever is first) for the subjects randomized to Treatment compared to subjects randomized to Control</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality Rates</measure>
      <time_frame>Following completion of the 30-day follow-up by all available randomized subjects</time_frame>
      <description>Compare 30-day mortality rates of Treatment and Control subjects</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Event Rates</measure>
      <time_frame>Following completion of the 30-day follow-up by all available randomized subjects</time_frame>
      <description>Compare adverse event rates for Treatment and Control subjects</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days on Mechanical Ventilation</measure>
      <time_frame>Following completion of the 30-day follow-up by all available randomized subjects</time_frame>
      <description>Compare number of days on mechanical ventilation from the date of randomization to removal of mechanical ventilation associated with successful weaning or Day 30, whichever comes first, for Treatment and Control subjects</description>
    </secondary_outcome>
    <other_outcome>
      <measure>pdSTIM System Summary</measure>
      <time_frame>Following completion of the 30-day follow-up by all available randomized subjects</time_frame>
      <description>Summarize pdSTIM System characteristics, such as lead placement success rate, duration of procedure, waveforms of flow/pressure, and pdSTIM System related complications</description>
    </other_outcome>
    <other_outcome>
      <measure>Mean Change in Rapid Shallow Breathing Index (RSBI)</measure>
      <time_frame>Following completion of the 30-day follow-up by all available randomized subjects</time_frame>
      <description>Compare the mean change in Rapid Shallow Breathing Index from randomization to Day 30 or removal of mechanical ventilation, whichever comes first, for Treatment and Control subjects</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of ICU Days</measure>
      <time_frame>Following completion of the 30-day follow-up by all available randomized subjects</time_frame>
      <description>Compare the number of ICU days from randomization to Day 30 or removal of mechanical ventilation, whichever comes first, for Treatment and Control subjects</description>
    </other_outcome>
    <other_outcome>
      <measure>Rate of Re-intubation</measure>
      <time_frame>Following completion of the 30-day follow-up by all available randomized subjects</time_frame>
      <description>Compare the rate of re-intubation following successful weaning for Treatment and Control subjects</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">420</enrollment>
    <condition>Ventilator Induced Diaphragm Dysfunction</condition>
    <arm_group>
      <arm_group_label>pdSTIM System Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>pdSTIM System Therapy</intervention_name>
      <description>Stimulate the phrenic nerves in synchrony with inspiratory cycles of the ventilator which exercises the diaphragm</description>
      <arm_group_label>pdSTIM System Therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject is 22 years or older.&#xD;
  &#xD;
            2. Subject, or subject's Legally Authorized Representative, understands study&#xD;
               requirements, study visits, and is willing and able to provide written informed&#xD;
               consent prior to study specific procedures or testing.&#xD;
  &#xD;
            3. Subject has been on mechanical ventilation for ≥ 96 hours prior to randomization&#xD;
               (intubation or tracheostomy).&#xD;
  &#xD;
            4. Subject has failed at least 1 weaning attempt (i.e., site directed spontaneous&#xD;
               breathing trial(s) did not result in liberation).&#xD;
  &#xD;
            5. At the time of enrollment, the subject is likely to be ventilated for an additional 48&#xD;
               hours, at minimum, in the opinion of the investigator.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject has Maximal Inspiratory Pressure (absolute value) &gt; 50 cmH2O.&#xD;
  &#xD;
            2. Subject has been on invasive mechanical ventilation for &gt; 45 days.&#xD;
  &#xD;
            3. Subject failed to wean due to pre-existing neurological or neuromuscular issues&#xD;
               affecting the respiratory muscles (e.g., ALS, phrenic nerve paralysis, inflammatory&#xD;
               muscle disease, underlying myopathy, myasthenia gravis, cervical spinal injury).&#xD;
  &#xD;
            4. Subject's medical history, known anatomy or investigator's inability to visualize&#xD;
               necessary anatomical landmarks that could prevent the safe placement of the pdSTIM&#xD;
               leads.&#xD;
  &#xD;
            5. Subject is at risk of significant hemorrhage or is currently receiving a full dose of&#xD;
               systemic anticoagulation (e.g., IV heparin, high dose of subcutaneous heparin.&#xD;
               Subjects on prophylactic anticoagulation or daily aspirin regimen on their own are not&#xD;
               excluded unless other exclusion criteria apply).&#xD;
  &#xD;
            6. Subject has an implant or external electrical device that may interact or interfere&#xD;
               with the pdSTIM System (examples may include cardiac pacemaker, implantable&#xD;
               defibrillator, vagal nerve stimulator, spinal cord stimulator, gastric stimulator,&#xD;
               diaphragmatic stimulator).&#xD;
  &#xD;
            7. Subject has been diagnosed and has been treated for neck cancer within the past 5&#xD;
               years or subject had any prior radiation treatment to the neck.&#xD;
  &#xD;
            8. Subject currently has hemodynamic instability due to any cause (e.g., severe sepsis,&#xD;
               hemorrhagic shock, or septic shock) with vasopressor support &gt; 0.1 mg/kg/min of&#xD;
               norepinephrine or epinephrine, or equivalent, or is actively being titrated.&#xD;
  &#xD;
            9. Subject has a local infection at or around the proposed pdSTIM Lead insertion site.&#xD;
  &#xD;
           10. Subject is neutropenic or has signs of significant immunocompromise. (Subjects&#xD;
               intubated for respiratory failure due to COVID-19 are not excluded unless other&#xD;
               exclusion criteria apply).&#xD;
  &#xD;
           11. Subject has severe COPD with evidence of significant expiratory obstruction on the&#xD;
               ventilator flow waveform.&#xD;
  &#xD;
           12. Subject has pre-existing severe chronic pulmonary fibrosis.&#xD;
  &#xD;
           13. Subject has pleural effusion occupying greater than 1/3 of the pleural space on either&#xD;
               side.&#xD;
  &#xD;
           14. Subject is currently on or expected to begin neuromuscular blockades.&#xD;
  &#xD;
           15. Subject has a severe head injury defined as having a Glasgow Coma Scale (GCS) score of&#xD;
               8 or less.&#xD;
  &#xD;
           16. Subject has a do-not-reintubate order.&#xD;
  &#xD;
           17. Subject is anticipating withdrawal of life support and/or shift to palliation as the&#xD;
               goal of care with less than 6-months life expectancy.&#xD;
  &#xD;
           18. Subject is known or suspected to be pregnant or lactating.&#xD;
  &#xD;
           19. Subject is currently enrolled in or exited early from a) any investigational drug&#xD;
               study or b) an investigational device study that may impact the ability to wean or is&#xD;
               directly related to the lungs or diaphragm.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Steven Conrad, MD,PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>LSU Health Sciences Shreveport</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Head of Clinical</last_name>
      <phone>612-445-8252</phone>
      <email>clinical@stimdia.com</email>
    </overall_contact>
    <link>
      <url>https://stimdia.com/</url>
      <description>Company Website</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Mechanical Ventilation</keyword>
    <keyword>Phrenic Nerve Stimulation</keyword>
    <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/NCT05998018
  org study id: CIP0002
  nct id: NCT05998018
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  This prospective, multi-center, randomized, controlled clinical trial is being conducted to
        evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical
        ventilation through phrenic nerve stimulation. Potential subjects who are on mechanical
        ventilation for at least four days and have failed at least one weaning attempt will be
        considered for the study. Those enrolled will be randomized in a 1:1 manner between the
        treatment group that is standard of care with the pdSTIM System and a Control group, which is
        standard of care alone.
  
        The primary endpoints focus on time to weaning and serious adverse event rates between the
        Treatment and Control groups.
  The pdSTIM Pivotal Study (ReInvigorate Study) is a prospective, multicenter, randomized,
        controlled clinical study to evaluate the safety and efficacy of the pdSTIM System to
        facilitate weaning from mechanical ventilation through phrenic nerve stimulation. Potential
        subjects who are on mechanical ventilation for ≥ 96 hours (4 days) and have failed at least
        one weaning attempt will be considered for the study.
  
        Those enrolled will be randomized in a 1:1 manner between a Treatment group that is standard
        of care with the pdSTIM System and a Control group that is standard of care only. For the
        Treatment group, stimulation therapy with pdSTIM will occur daily until the subject is
        successfully removed from mechanical ventilation or the 30-Day follow-up visit, whichever is
        sooner. All randomized subjects will be followed to 60 (± 7) days post randomization. Total
        subject participation will be no longer than 67 days.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Time to Wean
  time frame: Following completion of the 30-day follow-up by all available randomized subjects
  description: Assess time to successful weaning from mechanical ventilation for the subjects randomized to Treatment as compared to subjects randomized to Control
  measure: Assessment of Serious Adverse Events (SAEs)
  time frame: Following completion of the 30-day follow-up by all available randomized subjects
  description: Assessment of Serious Adverse Events (SAEs) for the subjects randomized to Treatment as compared to subjects randomized to Control
  measure: Mean Change in Maximal Inspiratory Pressure (MIP)
  time frame: Following completion of the 30-day follow-up by all available randomized subjects
  description: Assess mean change in maximal inspiratory pressure from baseline through Day 30 or at the time of successful weaning (whichever is first) for the subjects randomized to Treatment compared to subjects randomized to Control
  measure: Mortality Rates
  time frame: Following completion of the 30-day follow-up by all available randomized subjects
  description: Compare 30-day mortality rates of Treatment and Control subjects
  measure: Adverse Event Rates
  time frame: Following completion of the 30-day follow-up by all available randomized subjects
  description: Compare adverse event rates for Treatment and Control subjects
  measure: Days on Mechanical Ventilation
  time frame: Following completion of the 30-day follow-up by all available randomized subjects
  description: Compare number of days on mechanical ventilation from the date of randomization to removal of mechanical ventilation associated with successful weaning or Day 30, whichever comes first, for Treatment and Control subjects
  measure: pdSTIM System Summary
  time frame: Following completion of the 30-day follow-up by all available randomized subjects
  description: Summarize pdSTIM System characteristics, such as lead placement success rate, duration of procedure, waveforms of flow/pressure, and pdSTIM System related complications
  measure: Mean Change in Rapid Shallow Breathing Index (RSBI)
  time frame: Following completion of the 30-day follow-up by all available randomized subjects
  description: Compare the mean change in Rapid Shallow Breathing Index from randomization to Day 30 or removal of mechanical ventilation, whichever comes first, for Treatment and Control subjects
  measure: Number of ICU Days
  time frame: Following completion of the 30-day follow-up by all available randomized subjects
  description: Compare the number of ICU days from randomization to Day 30 or removal of mechanical ventilation, whichever comes first, for Treatment and Control subjects
  measure: Rate of Re-intubation
  time frame: Following completion of the 30-day follow-up by all available randomized subjects
  description: Compare the rate of re-intubation following successful weaning for Treatment and Control subjects
  arm group label: pdSTIM System Therapy
  arm group type: Experimental
  arm group label: Standard of Care
  arm group type: No Intervention
  intervention type: Device
  intervention name: pdSTIM System Therapy
  description: Stimulate the phrenic nerves in synchrony with inspiratory cycles of the ventilator which exercises the diaphragm
  arm group label: pdSTIM System Therapy
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Steven Conrad, MD,PhD
  role: Principal Investigator
  affiliation: LSU Health Sciences Shreveport
  last name: Head of Clinical
  phone: 612-445-8252
  email: clinical@stimdia.com
  url: https://stimdia.com/
  description: Company Website
  responsible party type: Sponsor
  sharing ipd: No