<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/NCT03240588</url>
  </required_header>
  <id_info>
    <org_study_id>92100126</org_study_id>
    <secondary_id>92366204</secondary_id>
    <nct_id>NCT03240588</nct_id>
  </id_info>
  <brief_title>NAVITAS and ENVISION</brief_title>
  <official_title>NAVITAS and ENVISION: A Study to Characterize the Relationship Between Select Objective Metrics and Clinical Outcomes in Chronic Pain Patients Treated With Boston Scientific Neurostimulation Systems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <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 objective of the study is to characterize the relationship between select objective&#xD;
      metrics and clinical outcomes in chronic pain patients treated with Boston Scientific&#xD;
      commercially approved neurostimulation systems.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>6 months</time_frame>
    <description>Mean difference in pain intensity between Baseline and 6 months post neurostimulation trial visit (pain intensity assessed using 0-10 numerical rating scale)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1900</enrollment>
  <condition>Pain, Chronic</condition>
  <arm_group>
    <arm_group_label>De Novo Cohort</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study subjects who have not previously attempted a Neurostimulator trial will be followed up to 36 months post-Neurostimulation trial procedure or IPG Activation on the use of their Neurostimulation system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Existing Cohort</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study subjects who have completed permanent neurostimulator IPG implant and are in various stages of follow-up will be followed up to 36 months post-Neurostimulation trial or IPG Activation procedure on the use of their Neurostimulation system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neurostimulation System</intervention_name>
    <description>Spinal cord stimulation</description>
    <arm_group_label>De Novo Cohort</arm_group_label>
    <arm_group_label>Existing Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
        - Is willing and able to comply with completing protocol required assessments and&#xD;
        evaluations&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
        - Has any pain-related diagnosis, medical/psychological condition or external factors that,&#xD;
        in the investigator's medical judgment, might confound reporting of study outcomes (e.g.&#xD;
        history of pelvic pain, anginal pain, chronic migraine, involved in litigation, workmen's&#xD;
        compensation)&#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>Natalie Bloom Lyons, M.S.</last_name>
    <role>Study Director</role>
    <affiliation>Boston Scientific Neuromodulation Corporation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gerard Herro, MS</last_name>
    <phone>855-213-9890</phone>
    <email>BSNClinicalTrials@bsci.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Diane Keesey</last_name>
    <phone>855-213-9890</phone>
    <email>BSNClinicalTrials@bsci.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hope Research Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Banner University Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Coastal Research Institute</name>
      <address>
        <city>Carlsbad</city>
        <state>California</state>
        <zip>92009</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>South Lake Pain Institute, Inc</name>
      <address>
        <city>Clermont</city>
        <state>Florida</state>
        <zip>34711</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Florida Shands Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tallahassee Neurological Clinic, PA</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Willis-Knighton River Cities Clinical Research Center</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Forest Health Medical Center</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48198</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>KC Pain Centers</name>
      <address>
        <city>Lee's Summit</city>
        <state>Missouri</state>
        <zip>64086</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Center for Clinical Research, LLC</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pacific Sports and Spine, LLC</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>PCPMG Clinical Research Unit, LLC</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Precision Spine Care</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Washington Center for Pain Management</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>EvergreenHealth Pain Care</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Advanced Pain Management Appleton</name>
      <address>
        <city>Greenfield</city>
        <state>Wisconsin</state>
        <zip>53221</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</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>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/NCT03240588
org study id: 92100126
secondary id: 92366204
nct id: NCT03240588
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective of the study is to characterize the relationship between select objective
      metrics and clinical outcomes in chronic pain patients treated with Boston Scientific
      commercially approved neurostimulation systems.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Intensity
time frame: 6 months
description: Mean difference in pain intensity between Baseline and 6 months post neurostimulation trial visit (pain intensity assessed using 0-10 numerical rating scale)
arm group label: De Novo Cohort
arm group type: Active Comparator
description: Study subjects who have not previously attempted a Neurostimulator trial will be followed up to 36 months post-Neurostimulation trial procedure or IPG Activation on the use of their Neurostimulation system.
arm group label: Existing Cohort
arm group type: Active Comparator
description: Study subjects who have completed permanent neurostimulator IPG implant and are in various stages of follow-up will be followed up to 36 months post-Neurostimulation trial or IPG Activation procedure on the use of their Neurostimulation system.
intervention type: Device
intervention name: Neurostimulation System
description: Spinal cord stimulation
arm group label: De Novo Cohort
arm group label: Existing Cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Natalie Bloom Lyons, M.S.
role: Study Director
affiliation: Boston Scientific Neuromodulation Corporation
last name: Gerard Herro, MS
phone: 855-213-9890
email: BSNClinicalTrials@bsci.com
last name: Diane Keesey
phone: 855-213-9890
email: BSNClinicalTrials@bsci.com
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain