<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/NCT02209896</url>
  </required_header>
  <id_info>
    <org_study_id>CP-04-001</org_study_id>
    <nct_id>NCT02209896</nct_id>
  </id_info>
  <brief_title>BlueWind Reprieve System for the Treatment of PNP</brief_title>
  <official_title>Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BlueWind Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BlueWind Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external&#xD;
      components.&#xD;
&#xD;
      The system is intended for home care use. The chronic pain treatment is achieved by an&#xD;
      electrical stimulation of peripheral nerve fibers. The stimulation is set so that it&#xD;
      generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and&#xD;
      improving the quality of life for the patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>The incidence of serious adverse events</measure>
    <time_frame>6 months</time_frame>
    <description>The incidence of serious adverse events (system and/or procedure related events)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>6 months post system activation</time_frame>
    <description>Pain assessment by Visual Analogue Scale (VAS) as compared to baseline at 6 months post activation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical success defined as the effect of the Reprieve System on patient's symptoms</measure>
    <time_frame>6 months post system activation</time_frame>
    <description>Measurements include:&#xD;
SF-McGill pain Questionnaire Pain related medication consumption/day Quality of life questionnaire SF-36 Health survey and safety</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Peripheral Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>BlueWind Reprieve System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Reprieve implant will be implanted for eligible patients. Implant parameters settings will be set according to patient's sensations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The Reprieve system</intervention_name>
    <description>BlueWind Medical neurostimulator for the treatment of neuropathic pain</description>
    <arm_group_label>BlueWind Reprieve System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed written informed consent.&#xD;
&#xD;
          -  Male or female aged 18 - 80.&#xD;
&#xD;
          -  Patient agrees to attend all follow-up evaluations and is willing to completely and&#xD;
             accurately fill out pain questionnaires.&#xD;
&#xD;
          -  Diagnosis of chronic neuropathic pain due to peripheral neuropathy.&#xD;
&#xD;
          -  Documented pain attributed to neuropathy for at least 6 months.&#xD;
&#xD;
          -  Pain intensity with an average daily VAS score of at least 6, demonstrated by 3&#xD;
             ratings per day across 7 days.&#xD;
&#xD;
          -  Patient refractory to conservative treatments including pain medication, for at least&#xD;
             6 months.&#xD;
&#xD;
          -  Stable pain medication for at least 4 weeks prior to study enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous participation in another study with any investigational drug or device within&#xD;
             the past 90 days.&#xD;
&#xD;
          -  Any active implant (cardiac or other).&#xD;
&#xD;
          -  Any metal implant in the area of BlueWind device implantation site.&#xD;
&#xD;
          -  Current pregnancy or attempting to get pregnant (female patient).&#xD;
&#xD;
          -  Any clinically significant neurologic disorders (except PNP).- Any clinically&#xD;
             significant or unstable medical or psychiatric condition that would affect the&#xD;
             patient's ability to participate in the study.&#xD;
&#xD;
          -  Patients with severe or unstable cardiovascular, pulmonary, gastrointestinal,&#xD;
             hematological, hepatic, renal or endocrine diseases.&#xD;
&#xD;
          -  Severe peripheral vascular disease that may cause intermittent claudication or&#xD;
             ischemic ulcers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ron Dabby, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wolfson Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam Health care campus</name>
      <address>
        <city>Haifa</city>
        <zip>3525408</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edith Wolfson Medical Center</name>
      <address>
        <city>Holon</city>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 3, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>April 10, 2018</last_update_submitted>
  <last_update_submitted_qc>April 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Peripheral Neuropathic Pain</keyword>
  <keyword>PNP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</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/NCT02209896
org study id: CP-04-001
nct id: NCT02209896
lead sponsor: 
has dmc: No
The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external
      components.

      The system is intended for home care use. The chronic pain treatment is achieved by an
      electrical stimulation of peripheral nerve fibers. The stimulation is set so that it
      generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and
      improving the quality of life for the patient.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The incidence of serious adverse events
time frame: 6 months
description: The incidence of serious adverse events (system and/or procedure related events)
measure: Pain assessment
time frame: 6 months post system activation
description: Pain assessment by Visual Analogue Scale (VAS) as compared to baseline at 6 months post activation
measure: Clinical success defined as the effect of the Reprieve System on patient's symptoms
time frame: 6 months post system activation
description: Measurements include:
SF-McGill pain Questionnaire Pain related medication consumption/day Quality of life questionnaire SF-36 Health survey and safety
arm group label: BlueWind Reprieve System
arm group type: Experimental
description: The Reprieve implant will be implanted for eligible patients. Implant parameters settings will be set according to patient's sensations.
intervention type: Device
intervention name: The Reprieve system
description: BlueWind Medical neurostimulator for the treatment of neuropathic pain
arm group label: BlueWind Reprieve System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ron Dabby, MD
role: Principal Investigator
affiliation: Wolfson Medical Center
facility: 
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Neuralgia