<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/NCT02250469</url>
  </required_header>
  <id_info>
    <org_study_id>12-SMI-2014</org_study_id>
    <nct_id>NCT02250469</nct_id>
  </id_info>
  <brief_title>A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems</brief_title>
  <acronym>CHARACTER SCS</acronym>
  <official_title>A Randomised Pilot Study to Assess differenCes in tHe Subjects' Experience of stimulAtion-Induced paRaesthesiA Between Two Different Spinal Cord sTimulation dEvices: the Axium® DoRsal Root Ganglion Stimulation System Versus the Prime Advanced Dorsal Column Stimulation System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in&#xD;
      patient experiences with two different types of Spinal Cord Stimulator devices which are&#xD;
      routinely used to treat chronic pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Specificity of Stimulation Induced Paresthesia</measure>
    <time_frame>3 Months post implantation</time_frame>
    <description>A comparative analysis will be made between groups to determine the percentage of a patients painful and non-painful anatomy that is covered by stimulation induced paresthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stability of Stimulation Induced Paresthesia</measure>
    <time_frame>3 Months post implantation</time_frame>
    <description>A comparative analysis will be made between groups to determine any changes in the intensity of stimulation induced paresthesia in response to changes in body position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Interactions with System</measure>
    <time_frame>3 Months post implantation</time_frame>
    <description>A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Axium SCS System</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implantation with the Axium Neurostimulator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medtronic SCS System</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Treatment with the Axium SCS system</intervention_name>
    <arm_group_label>Axium SCS System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Treatment with the Medtronic SCS System</intervention_name>
    <arm_group_label>Medtronic SCS System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is appropriate for SCS implantation according to standard criteria&#xD;
&#xD;
          2. Subject is &gt;18 to &lt;75 years old&#xD;
&#xD;
          3. Subject is able and willing to comply with the follow-up schedule and protocol&#xD;
&#xD;
          4. Subject has chronic (&gt; 6 months) uni/bi-lateral neuropathic pain in the lower limb(s)&#xD;
             (below the knee) with predominant foot pain&#xD;
&#xD;
          5. Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain&#xD;
&#xD;
          6. Subject is able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has no other exclusion criteria for SCS implantation according to standard&#xD;
             criteria&#xD;
&#xD;
          2. Subject has had corticosteroid therapy at an intended site of stimulation within the&#xD;
             past 30 days&#xD;
&#xD;
          3. Subject has had radiofrequency treatment of an intended target DRG within the past 3&#xD;
             months&#xD;
&#xD;
          4. Subject has participated in another clinical study within 30 days&#xD;
&#xD;
          5. Subject has been previously treated with and failed to respond to an implantable&#xD;
             neuromodulation therapy&#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>M W Hollmann, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>AIDS Malignancy Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Academisch Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paresthesia</mesh_term>
    <mesh_term>Chronic Pain</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/NCT02250469
org study id: 12-SMI-2014
nct id: NCT02250469
lead sponsor: 
has dmc: No
12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in
      patient experiences with two different types of Spinal Cord Stimulator devices which are
      routinely used to treat chronic pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Specificity of Stimulation Induced Paresthesia
time frame: 3 Months post implantation
description: A comparative analysis will be made between groups to determine the percentage of a patients painful and non-painful anatomy that is covered by stimulation induced paresthesia
measure: Stability of Stimulation Induced Paresthesia
time frame: 3 Months post implantation
description: A comparative analysis will be made between groups to determine any changes in the intensity of stimulation induced paresthesia in response to changes in body position
measure: Patient Interactions with System
time frame: 3 Months post implantation
description: A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily
arm group label: Axium SCS System
arm group type: Active Comparator
description: Implantation with the Axium Neurostimulator
arm group label: Medtronic SCS System
arm group type: Active Comparator
description: Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System
intervention type: Device
intervention name: Treatment with the Axium SCS system
arm group label: Axium SCS System
intervention type: Device
intervention name: Treatment with the Medtronic SCS System
arm group label: Medtronic SCS System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: M W Hollmann, Prof
role: Principal Investigator
affiliation: AIDS Malignancy Consortium
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Paresthesia
mesh term: Chronic Pain