<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/NCT04457427</url>
  </required_header>
  <id_info>
    <org_study_id>CLIN 20-1000-35</org_study_id>
    <nct_id>NCT04457427</nct_id>
  </id_info>
  <brief_title>Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation</brief_title>
  <official_title>Prospective, Single-center, Randomized Clinical Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Synapse Biomedical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Synapse Biomedical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized prospective, single-center feasibility study of the use and&#xD;
      benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      15 patients undergoing tracheostomy for failure to wean will be randomized into one of 3&#xD;
      cohorts (5 in each cohort): Cohort A: tracheostomy with no intervention; Cohort B:&#xD;
      tracheostomy with DPS implantation and immediate stimulation and monitoring and Cohort C:&#xD;
      tracheostomy with DPS implantation with monitoring followed with stimulation on day 5.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study not started&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2016</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">March 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Device and procedure safety</measure>
    <time_frame>Through study completion, an average of 6 years</time_frame>
    <description>Device or procedure-related adverse events from time of implant until removal of electrodes prior to discharge from the hospital or 30 days, whichever occurs first</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Monitoring</measure>
    <time_frame>Through study completion, an average of 6 years</time_frame>
    <description>Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stimulation</measure>
    <time_frame>Through study completion, an average of 6 years</time_frame>
    <description>Increase in magnitude of diaphragm burst activity with stimulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effects of diaphragm stimulation</measure>
    <time_frame>Through study completion, an average of 6 years</time_frame>
    <description>Effects of diaphragm stimulation on ventilator parameters (plateau pressure, compliance, tidal volumes), oxygenation, weaning time, extubation failure, and length of stay</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Electrode removal</measure>
    <time_frame>Through study completion, an average of 6 years</time_frame>
    <description>(3) Safe and complete removal of electrodes prior to discharge from the hospital or thirty (30) days, whichever occurs first</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diaphragm Issues</condition>
  <condition>Ventilator-Induced Lung Injury</condition>
  <condition>Tracheostomy</condition>
  <arm_group>
    <arm_group_label>Tracheostomy, no DPS</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>5 patients undergoing tracheostomy for failure to wean will receive no additional intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trachesotomy with immediate DPS stimulation and monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate stimulation and monitoring.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trachesotomy with DPS monitoring, stimulation on day 5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate monitoring followed by stimulation on day 5 post-procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NeuRx Diaphragm Pacing System (DPS)</intervention_name>
    <description>4 electrodes are implanted into the diaphragm, 2 on each side, during the tracheostomy procedure. The electrodes are connected to the NeuRx external stimulator which will be used to stimulate and monitor diaphragm activity.</description>
    <arm_group_label>Trachesotomy with DPS monitoring, stimulation on day 5</arm_group_label>
    <arm_group_label>Trachesotomy with immediate DPS stimulation and monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is intubated, on mechanical ventilation, undergoing tracheostomy, and expected&#xD;
             to undergo mechanical ventilation for at least 5 days&#xD;
&#xD;
          -  Signed written informed consent has been obtained prior to performing any study&#xD;
             related procedure(s)&#xD;
&#xD;
          -  Subject is at least 18 years of age&#xD;
&#xD;
          -  Negative pregnancy test if the patient is a female of child-bearing potential.&#xD;
             (Females of child-bearing potential exclude women who are post-hysterectomy or&#xD;
             post-menopausal.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diaphragm malformation which makes electrode insertion impossible&#xD;
&#xD;
          -  Presence of an implantable cardioverter-defibrillator&#xD;
&#xD;
          -  Severe chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
          -  Subject is pregnant or breastfeeding&#xD;
&#xD;
          -  Diagnosis of neuromuscular disease or high level spinal cord injury prior to&#xD;
             tracheostomy&#xD;
&#xD;
          -  Terminal patients expected to die during their stay in the hospital&#xD;
&#xD;
          -  Participation in other clinical studies that could interfere with the results in the&#xD;
             ongoing study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tunç Laçin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Marmara University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marmara Univeristy</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://www.synapsebiomedical.com/</url>
    <description>Click here for more information about the Sponsor.</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>March 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mechanical Ventilators</keyword>
  <keyword>Ventilators, Pulmonary</keyword>
  <keyword>Failure to wean</keyword>
  <keyword>Lung Injury, Ventilator-Induced</keyword>
  <keyword>Tracheostomy</keyword>
  <keyword>Diaphragm pacing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Injury</mesh_term>
    <mesh_term>Ventilator-Induced Lung Injury</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04457427
org study id: CLIN 20-1000-35
nct id: NCT04457427
lead sponsor: 
has dmc: No
This study is a randomized prospective, single-center feasibility study of the use and
      benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.
15 patients undergoing tracheostomy for failure to wean will be randomized into one of 3
      cohorts (5 in each cohort): Cohort A: tracheostomy with no intervention; Cohort B:
      tracheostomy with DPS implantation and immediate stimulation and monitoring and Cohort C:
      tracheostomy with DPS implantation with monitoring followed with stimulation on day 5.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Device and procedure safety
time frame: Through study completion, an average of 6 years
description: Device or procedure-related adverse events from time of implant until removal of electrodes prior to discharge from the hospital or 30 days, whichever occurs first
measure: Monitoring
time frame: Through study completion, an average of 6 years
description: Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction
measure: Stimulation
time frame: Through study completion, an average of 6 years
description: Increase in magnitude of diaphragm burst activity with stimulation
measure: Effects of diaphragm stimulation
time frame: Through study completion, an average of 6 years
description: Effects of diaphragm stimulation on ventilator parameters (plateau pressure, compliance, tidal volumes), oxygenation, weaning time, extubation failure, and length of stay
measure: Electrode removal
time frame: Through study completion, an average of 6 years
description: (3) Safe and complete removal of electrodes prior to discharge from the hospital or thirty (30) days, whichever occurs first
arm group label: Tracheostomy, no DPS
arm group type: No Intervention
description: 5 patients undergoing tracheostomy for failure to wean will receive no additional intervention.
arm group label: Trachesotomy with immediate DPS stimulation and monitoring
arm group type: Experimental
description: 5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate stimulation and monitoring.
arm group label: Trachesotomy with DPS monitoring, stimulation on day 5
arm group type: Active Comparator
description: 5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate monitoring followed by stimulation on day 5 post-procedure.
intervention type: Device
intervention name: NeuRx Diaphragm Pacing System (DPS)
description: 4 electrodes are implanted into the diaphragm, 2 on each side, during the tracheostomy procedure. The electrodes are connected to the NeuRx external stimulator which will be used to stimulate and monitor diaphragm activity.
arm group label: Trachesotomy with DPS monitoring, stimulation on day 5
arm group label: Trachesotomy with immediate DPS stimulation and monitoring
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tunç Laçin, MD
role: Principal Investigator
affiliation: Marmara University
facility: 
country: Turkey
url: http://www.synapsebiomedical.com/
description: Click here for more information about the Sponsor.
responsible party type: Sponsor
mesh term: Lung Injury
mesh term: Ventilator-Induced Lung Injury