<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/NCT04503109</url>
  </required_header>
  <id_info>
    <org_study_id>NAL-01-2020-US</org_study_id>
    <nct_id>NCT04503109</nct_id>
  </id_info>
  <brief_title>Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System</brief_title>
  <acronym>nPower™-US</acronym>
  <official_title>Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nalu Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nalu Medical, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Nalu Neurostimulation System is capable of delivering multiple therapy options to address&#xD;
      patient needs. The study will confirm the efficacy, safety, comfort and compliance with the&#xD;
      Nalu Neurostimulation System in adult subjects with chronic pain in the legs and back.&#xD;
      Patients who have been diagnosed with failed back surgery syndrome (FBSS) and meet other&#xD;
      study eligibility criteria will be enrolled in the study to receive the Nalu Neurostimulation&#xD;
      System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective, multi-center, open-label, single-arm clinical study with each&#xD;
      subject serving as their own control. The study will confirm device efficacy, safety, comfort&#xD;
      and compliance with the system.&#xD;
&#xD;
      Subjects who meet the protocol specified eligibility criteria and provide documented informed&#xD;
      consent will be considered for study participation. There are three phases in the study:&#xD;
      Screening/Baseline Phase, Trial Phase, Permanent Implant Phase. On confirmation of&#xD;
      eligibility during the screening/baseline phase, subjects will enter the Trial Phase where&#xD;
      they will undergo a trial with the Nalu Neurostimulation System. Trials will be done per&#xD;
      standard clinical practice and per system IFU. Subjects receiving at least 50% reduction in&#xD;
      their back pain, during the trial phase, will continue to the permanent implant phase.&#xD;
&#xD;
      Eligible subjects will receive the Nalu Neurostimulation System per standard surgical and&#xD;
      medical practices and will be programmed for stimulation with one or more therapies to&#xD;
      optimize pain reduction. All subjects receiving a permanent implant will be followed for&#xD;
      3-months post device activation. They will visit the clinic at 1 month and 3-months follow-up&#xD;
      and programming, as required. Adverse Event data will also be collected to support a safety&#xD;
      endpoint.&#xD;
&#xD;
      Multiple outcome domains will be captured throughout the study to confirm system performance&#xD;
      and subject response to the device. These include Visual Analogue Scale (VAS) for pain,&#xD;
      Numeric Rating Scales for pain, EQ-5D (QoL), the Oswestry Disability Index (ODI), PROMIS&#xD;
      Sleep Disturbance SF, Beck's Depression Index (BDI), pain and paresthesia maps, pain and&#xD;
      wearability diaries.&#xD;
&#xD;
      At study completion, subjects will return to standard clinical practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Actual">September 13, 2022</completion_date>
  <primary_completion_date type="Actual">September 13, 2022</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>Responders at 3-months</measure>
    <time_frame>3 months</time_frame>
    <description>Number of subjects who have 50% or greater pain reduction from baseline</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Pain, Chronic</condition>
  <condition>Pain, Intractable</condition>
  <condition>Pain, Back</condition>
  <arm_group>
    <arm_group_label>Nalu SCS System</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All eligible subjects will receive the Nalu Neurostimulation System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nalu Neurostimulation System</intervention_name>
    <description>The Nalu Neurostimulation System is a Spinal Cord Stimulation system</description>
    <arm_group_label>Nalu SCS System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is between 21 and 80 years of age at enrollment.&#xD;
&#xD;
          2. Subject has chronic (defined as at least 6 months duration), intractable neuropathic&#xD;
             pain of legs and/or back; any nociceptive pain must be less prominent than the&#xD;
             neuropathic pain.&#xD;
&#xD;
          3. Subject's pain is unresponsive to conservative treatment options.&#xD;
&#xD;
          4. Subject has a VAS Score of at least 6 in the back and/or leg at screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject currently has an active implantable medical device such as a drug pump, spinal&#xD;
             cord stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac&#xD;
             pacemaker.&#xD;
&#xD;
          2. Subject has previously failed SCS therapy (either trial system evaluation or permanent&#xD;
             implant).&#xD;
&#xD;
          3. Subject has had an ablative procedure directed at the spinal cord including the dorsal&#xD;
             root entry zone (DREZ) or dorsal root ganglion (DRG).&#xD;
&#xD;
          4. Subject has pain in another anatomic region besides the leg(s) and back that would&#xD;
             interfere with their ability to accurately report pain (e.g. hip joint pain).&#xD;
&#xD;
          5. Subject has a medical condition that would prevent them from participating in the&#xD;
             current study per investigator's or medical monitor's judgment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick Martin</last_name>
    <role>Study Director</role>
    <affiliation>Nalu Medical</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CA Ortho and Spine</name>
      <address>
        <city>Larkspur</city>
        <state>California</state>
        <zip>94939</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPM Medical Group, Inc.</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Spine, Pain and Performance Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Orthopaedic Institute</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Florida Pain Center</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33948</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Spine and Pain</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30326</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuroscience Research Center</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SSM Health</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spinal Cord Stimulation</keyword>
  <keyword>Chronic Leg and Back Pain</keyword>
  <keyword>Failed Back Surgery Syndrome (FBSS)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Pain, Intractable</mesh_term>
    <mesh_term>Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04503109
org study id: NAL-01-2020-US
nct id: NCT04503109
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The Nalu Neurostimulation System is capable of delivering multiple therapy options to address
      patient needs. The study will confirm the efficacy, safety, comfort and compliance with the
      Nalu Neurostimulation System in adult subjects with chronic pain in the legs and back.
      Patients who have been diagnosed with failed back surgery syndrome (FBSS) and meet other
      study eligibility criteria will be enrolled in the study to receive the Nalu Neurostimulation
      System.
The study is a prospective, multi-center, open-label, single-arm clinical study with each
      subject serving as their own control. The study will confirm device efficacy, safety, comfort
      and compliance with the system.

      Subjects who meet the protocol specified eligibility criteria and provide documented informed
      consent will be considered for study participation. There are three phases in the study:
      Screening/Baseline Phase, Trial Phase, Permanent Implant Phase. On confirmation of
      eligibility during the screening/baseline phase, subjects will enter the Trial Phase where
      they will undergo a trial with the Nalu Neurostimulation System. Trials will be done per
      standard clinical practice and per system IFU. Subjects receiving at least 50% reduction in
      their back pain, during the trial phase, will continue to the permanent implant phase.

      Eligible subjects will receive the Nalu Neurostimulation System per standard surgical and
      medical practices and will be programmed for stimulation with one or more therapies to
      optimize pain reduction. All subjects receiving a permanent implant will be followed for
      3-months post device activation. They will visit the clinic at 1 month and 3-months follow-up
      and programming, as required. Adverse Event data will also be collected to support a safety
      endpoint.

      Multiple outcome domains will be captured throughout the study to confirm system performance
      and subject response to the device. These include Visual Analogue Scale (VAS) for pain,
      Numeric Rating Scales for pain, EQ-5D (QoL), the Oswestry Disability Index (ODI), PROMIS
      Sleep Disturbance SF, Beck's Depression Index (BDI), pain and paresthesia maps, pain and
      wearability diaries.

      At study completion, subjects will return to standard clinical practice.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Responders at 3-months
time frame: 3 months
description: Number of subjects who have 50% or greater pain reduction from baseline
arm group label: Nalu SCS System
arm group type: Other
description: All eligible subjects will receive the Nalu Neurostimulation System
intervention type: Device
intervention name: Nalu Neurostimulation System
description: The Nalu Neurostimulation System is a Spinal Cord Stimulation system
arm group label: Nalu SCS System
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Patrick Martin
role: Study Director
affiliation: Nalu Medical
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Pain, Intractable
mesh term: Back Pain
sharing ipd: No