<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/NCT04466111</url>
  </required_header>
  <id_info>
    <org_study_id>DTM-PROC-2020PM3</org_study_id>
    <nct_id>NCT04466111</nct_id>
  </id_info>
  <brief_title>Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain</brief_title>
  <acronym>PROC2020PM</acronym>
  <official_title>A Post-Market, Observational Clinical Study to Evaluate the Effects of Differential Target Multiplexed DTM™ SCS Programming in Treating Intractable Chronic Upper Extremity Limb Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SGX Procura LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SGX Medical LLC</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a post-market, open-label, prospective, multi-center, observational study evaluating&#xD;
      upper limb pain relief with the DTM™ SCS programming approach.&#xD;
&#xD;
      Data at follow-up visits will be compared to baseline assessments collected at the beginning&#xD;
      of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a post-market, open-label, prospective, multi-center, observational study evaluating&#xD;
      upper limb pain relief with the DTM™ SCS programming approach.&#xD;
&#xD;
      Data at follow-up visits will be compared to baseline assessments collected at the beginning&#xD;
      of the study.&#xD;
&#xD;
      The expected total duration of this study is approximately 26 months. Enrollment of&#xD;
      participants is expected to last 20 months. Participants that have received the permanent&#xD;
      implant will be followed up for 12 months after their device has been activated. A&#xD;
      participant will likely be committed to the study for about 14 months. This consists of&#xD;
      Baseline assessments, up to 10 days of trial stimulation, and 12 months of treatment&#xD;
      following implantation and activation of the device. All subjects who plan on remaining&#xD;
      implanted through the 6-month visit or who have completed their 6-month visit will be offered&#xD;
      to return for an additional 12-month visit. This would increase their commitment to the study&#xD;
      to 14 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2020</start_date>
  <completion_date type="Actual">March 9, 2023</completion_date>
  <primary_completion_date type="Actual">July 29, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of implanted subjects who respond to DTM SCS therapy at 3-months</measure>
    <time_frame>3 months</time_frame>
    <description>The primary efficacy endpoint is the percentage of implanted subjects who respond to DTM SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in upper limb pain relative to baseline assessment.</description>
  </primary_outcome>
  <enrollment type="Actual">58</enrollment>
  <condition>Upper Limb</condition>
  <condition>Pain</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intellis neurostimulator system</intervention_name>
    <description>The study will use the commercially available IntellisTM neurostimulator and compatible SCS system components from Medtronic using stimulation parameters within the specifications approved for use in the approved indications. The study will stimulate the cervical dorsal columns of the spinal cord.</description>
    <other_name>Spinal Cord Stimulation (SCS) device system</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The intended study population is individuals who have been diagnosed with chronic,&#xD;
        intractable pain of the upper limbs associated with a number of conditions, and who the&#xD;
        Principal Investigator deems is an appropriate candidate for SCS therapy as required for&#xD;
        this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A subject must MEET ALL of the following inclusion criteria:&#xD;
&#xD;
               1. Be diagnosed with chronic, intractable pain of the upper limb related to the&#xD;
                  cervical spine and/or neuropathic arm pain.&#xD;
&#xD;
               2. Be a candidate for SCS system (trial and implant) per labeled indication (upper&#xD;
                  limb pain due to one of the conditions listed in indications statement)&#xD;
&#xD;
               3. Considering daily activity and rest, has average upper limb pain intensity of ≥ 5&#xD;
                  out of 10 cm on the Visual Analog Scale (VAS) at enrollment&#xD;
&#xD;
               4. Be willing and capable of giving written informed consent to participate in this&#xD;
                  clinical study based on voluntary agreement after a thorough explanation of the&#xD;
                  subject's participation has been provided.&#xD;
&#xD;
               5. Be willing and capable of subjective evaluation, read and understand written&#xD;
                  questionnaires, and read, understand and sign the written inform consent.&#xD;
&#xD;
               6. Be 18 years of age or older at the time of enrollment&#xD;
&#xD;
               7. Be on a stable pain medication regime, as determined by the study investigator,&#xD;
                  for at least 30 days prior to enrolling in this study&#xD;
&#xD;
               8. Be willing and able to comply with study -related requirements, procedures, and&#xD;
                  visits, including not increasing pain meds through the three month visit&#xD;
&#xD;
               9. Has adequate cognitive ability to use a patient programmer and recharger as&#xD;
                  determined by the Investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A subject must NOT MEET ANY of the following exclusion criteria:&#xD;
&#xD;
               1. Has a medical, anatomical, and/or psychosocial condition that is contraindicated&#xD;
                  for commercially available IntellisTM SCS systems as determined by the&#xD;
                  Investigator&#xD;
&#xD;
               2. Have a medical condition or pain in other area(s), not intended to be treated&#xD;
                  with SCS, that could interfere with study procedures, as determined by the&#xD;
                  Investigator&#xD;
&#xD;
               3. Currently enrolled or planning to enroll in an interventional clinical study that&#xD;
                  could potentially confound the study results (co-enrollment in an interventional&#xD;
                  study is only allowed when documented pre-approval is obtained from the study&#xD;
                  manager or designee)&#xD;
&#xD;
               4. Has an existing active implanted device such as a pacemaker, another SCS unit,&#xD;
                  peripheral nerve stimulator, and/or drug delivery pump.&#xD;
&#xD;
               5. Has pain in other area(s) and/or medical condition requiring the regular use of&#xD;
                  significant pain medications that could interfere with accurate pain reporting,&#xD;
                  study procedures, and/or confound evaluation of study endpoints, as determined by&#xD;
                  the Investigator&#xD;
&#xD;
               6. Has significant cervical stenosis, as determined by the Investigator&#xD;
&#xD;
               7. Has facet spondylosis, as determined by the Investigator&#xD;
&#xD;
               8. Has mechanical spine instability, as determined by the Investigator&#xD;
&#xD;
               9. Has undergone, within 30 days prior to enrollment, an interventional procedure&#xD;
                  and/or surgery to treat upper limb pain, which is providing significant pain&#xD;
                  relief&#xD;
&#xD;
              10. Has unresolved major issues of secondary gain (e.g., social, financial, legal,&#xD;
                  such as worker compensation matters)&#xD;
&#xD;
              11. Be pregnant as determined by urine testing unless female subject is surgically&#xD;
                  sterile or post-menopausal. If female, sexually active, and childbearing age,&#xD;
                  subject must be willing to use a reliable form of birth control.&#xD;
&#xD;
              12. Have evidence of an active disruptive psychological or psychiatric disorder as&#xD;
                  determined by a psychologist&#xD;
&#xD;
              13. Have a current diagnosis of a progressive neurological disease as determined by&#xD;
                  the Investigator&#xD;
&#xD;
              14. Have a current diagnosis of a coagulation disorder, bleeding diathesis,&#xD;
                  progressive peripheral vascular disease or uncontrolled diabetes mellitus&#xD;
&#xD;
              15. Have a condition that the Investigator determines would significantly increase&#xD;
                  perioperative risk&#xD;
&#xD;
              16. Any previous history of surgery on the posterior elements (laminectomy, posterior&#xD;
                  fusion) of the cervical spine&#xD;
&#xD;
              17. Have metastatic malignant disease or active local malignant disease&#xD;
&#xD;
              18. Have a life expectancy of less than 1 year&#xD;
&#xD;
              19. Have an active systemic or local infection&#xD;
&#xD;
              20. Have within 6 months of enrollment a significant untreated addiction to&#xD;
                  dependency producing medications or have been a substance abuser (including&#xD;
                  alcohol and illicit drugs)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SGX Medical</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>April 16, 2023</last_update_submitted>
  <last_update_submitted_qc>April 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>upper limb</keyword>
  <keyword>Spinal Cord Stimulation</keyword>
  <keyword>Pain</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 5, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04466111
org study id: DTM-PROC-2020PM3
nct id: NCT04466111
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a post-market, open-label, prospective, multi-center, observational study evaluating
      upper limb pain relief with the DTM™ SCS programming approach.

      Data at follow-up visits will be compared to baseline assessments collected at the beginning
      of the study.
This is a post-market, open-label, prospective, multi-center, observational study evaluating
      upper limb pain relief with the DTM™ SCS programming approach.

      Data at follow-up visits will be compared to baseline assessments collected at the beginning
      of the study.

      The expected total duration of this study is approximately 26 months. Enrollment of
      participants is expected to last 20 months. Participants that have received the permanent
      implant will be followed up for 12 months after their device has been activated. A
      participant will likely be committed to the study for about 14 months. This consists of
      Baseline assessments, up to 10 days of trial stimulation, and 12 months of treatment
      following implantation and activation of the device. All subjects who plan on remaining
      implanted through the 6-month visit or who have completed their 6-month visit will be offered
      to return for an additional 12-month visit. This would increase their commitment to the study
      to 14 months.
observational model: Other
time perspective: Prospective
measure: Percentage of implanted subjects who respond to DTM SCS therapy at 3-months
time frame: 3 months
description: The primary efficacy endpoint is the percentage of implanted subjects who respond to DTM SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in upper limb pain relative to baseline assessment.
intervention type: Device
intervention name: Intellis neurostimulator system
description: The study will use the commercially available IntellisTM neurostimulator and compatible SCS system components from Medtronic using stimulation parameters within the specifications approved for use in the approved indications. The study will stimulate the cervical dorsal columns of the spinal cord.
other name: Spinal Cord Stimulation (SCS) device system
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided
submitted: September 5, 2023