<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/NCT03285113</url>
  </required_header>
  <id_info>
    <org_study_id>CTC1601</org_study_id>
    <nct_id>NCT03285113</nct_id>
  </id_info>
  <brief_title>A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain</brief_title>
  <official_title>A Single-arm, Open Label, Single Center Pilot Study to Confirm the Safety of Dorsal Root Ganglia (DRG) and Ultrahigh Frequency Spinal Cord Stimulator in Patients With Chronic Lower Limb Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GiMer Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>GiMer Medical</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, single-arm, open label, single center pilot study to confirm the&#xD;
      safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The&#xD;
      actual trial length is 5 days. Pts will be given ultrahigh frequency pulse stimulation, and&#xD;
      VAS will be obtained after 3-4 hours of each stimulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, single-arm, open label, single center pilot study to confirm the&#xD;
      safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The&#xD;
      actual trial length is 5 days. An initial eligibility screening within Day -14. Pt admitted&#xD;
      to hospital on Day 1. The lead implantation is conducted on Day 2, and the 1st treatment&#xD;
      starts after anesthesia recovery (Day 2 T1). If VAS &gt;4 at 4 hours after the 1st treatment,&#xD;
      the 2nd treatment will be conducted. VAS will be acquired 4 hours after the 2nd treatment. On&#xD;
      Day 3, physical examination and vital signs will be collected. If VAS &gt;4, the 3rd treatment&#xD;
      will be provided. One hour after the 3rd treatment, the device will be removed and an X-ray&#xD;
      will be taken. Three hours after the removal, VAS will be collected and then the patient will&#xD;
      be discharged. VAS will be estimated by phone call on Day 4, and the patient will return to&#xD;
      OPD for follow up examination on Day 5. The trial is completed on Day 5 visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2017</start_date>
  <completion_date type="Actual">February 5, 2018</completion_date>
  <primary_completion_date type="Actual">February 5, 2018</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>Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE)</measure>
    <time_frame>5 days</time_frame>
    <description>Number of Participants with Adverse Events and Serious Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Measured by Visual Analog Scale (VAS)</measure>
    <time_frame>4 days</time_frame>
    <description>VAS: 0 (no pain) to 10 (max pain). Change in pain as a result of ultrahigh frequency DRG stimulation, as measured by VAS score compare to baseline VAS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Paresthesia</measure>
    <time_frame>2 days</time_frame>
    <description>If patients feel tingling during stimulation?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Medication Consumption</measure>
    <time_frame>5 days</time_frame>
    <description>Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Failed Back Surgery Syndrome</condition>
  <condition>Complex Regional Pain Syndrome (CRPS)</condition>
  <arm_group>
    <arm_group_label>Ultrahigh Frequency Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GiMer Medical MN 1000 External Stimulator</intervention_name>
    <description>Trial stimulator to generate pulsed ultrahigh frequency (&gt;200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.</description>
    <arm_group_label>Ultrahigh Frequency Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≧20 and ≦75&#xD;
&#xD;
          2. Have a symptom of complex regional pain syndrome (CRPS), failed back surgery syndrome&#xD;
             (FBSS), lower limb pain with or without lower back pain with a diagnosis related to&#xD;
             spinal lesion and pain history of &gt;6 months.&#xD;
&#xD;
          3. Have an average pain score &gt;5 by Visual Analogue Scale (VAS) on inclusion.&#xD;
&#xD;
          4. Has failed to achieve adequate pain relief from prior pharmacologic treatments.&#xD;
&#xD;
          5. In the judgement of the investigator, the subject is an appropriate candidate for the&#xD;
             trial procedure&#xD;
&#xD;
          6. The subject is willing and able to comply with the procedure and requirements of this&#xD;
             trial.&#xD;
&#xD;
          7. The participant is able to understand and provide informed consent, and has signed&#xD;
             their written informed consent in accordance with IRB requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have evidence of a mental or psychological condition that affects pain perception and&#xD;
             has difficulty/disability performing objective pain assessment, or have previously&#xD;
             failed mental or psychological assessments administered by a psychiatrist that may be&#xD;
             deemed to indicate the subject's lack of suitability for participation in this study.&#xD;
&#xD;
          2. Subject has exhibited escalating or changing pain condition within the past 30 days as&#xD;
             evidenced by Investigator examination.&#xD;
&#xD;
          3. Be on anticoagulant medication with INR &gt;1.5 or platelet count less than 100,000/μL,&#xD;
             peripheral vascular diseases (PVDs), visceral pain or uncontrolled Diabetes mellitus&#xD;
             (DM).&#xD;
&#xD;
          4. Has had corticosteroid therapy at an intended site of stimulation within the past 30&#xD;
             days.&#xD;
&#xD;
          5. Pain medication(s) dosages(s) are not stable for at least 30 days.&#xD;
&#xD;
          6. Has previously failed spinal cord stimulation therapy.&#xD;
&#xD;
          7. Currently has an active implantable device including ICD, pacemaker, spinal cord&#xD;
             stimulator or intrathecal drug pump or subject requires magnetic resonance imaging&#xD;
             (MRIs) or diathermy.&#xD;
&#xD;
          8. Has pain only within a cervical or thoracic distribution.&#xD;
&#xD;
          9. Have a current diagnosis of cancer with active symptoms&#xD;
&#xD;
         10. Have a known terminal illness with life expectancy less than one year&#xD;
&#xD;
         11. Have a systematic or local infection&#xD;
&#xD;
         12. Currently has an indwelling device that may pose an increased risk of infection.&#xD;
&#xD;
         13. Be pregnant or breast feeding&#xD;
&#xD;
         14. Have a medical history of drug or alcohol addiction within the past 2 years.&#xD;
&#xD;
         15. Participation in any investigational study in the last 30 days or current enrollment&#xD;
             in any trial.&#xD;
&#xD;
         16. Be currently involved in an injury claim law suit or medically related litigation,&#xD;
             including workers compensation.&#xD;
&#xD;
         17. Be a prisoner.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <results_first_submitted>June 5, 2020</results_first_submitted>
  <results_first_submitted_qc>December 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 22, 2021</results_first_posted>
  <last_update_submitted>December 29, 2020</last_update_submitted>
  <last_update_submitted_qc>December 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</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>Complex Regional Pain Syndromes</mesh_term>
    <mesh_term>Reflex Sympathetic Dystrophy</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Failed Back Surgery Syndrome</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03285113/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ultrahigh Frequency Stimulation</title>
          <description>Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.&#xD;
GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (&gt;200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Unable to implant leads</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ultrahigh Frequency Stimulation</title>
          <description>Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.&#xD;
GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (&gt;200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.5" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE)</title>
        <description>Number of Participants with Adverse Events and Serious Adverse Events</description>
        <time_frame>5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrahigh Frequency Stimulation</title>
            <description>Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.&#xD;
GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (&gt;200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE)</title>
          <description>Number of Participants with Adverse Events and Serious Adverse Events</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pain Measured by Visual Analog Scale (VAS)</title>
        <description>VAS: 0 (no pain) to 10 (max pain). Change in pain as a result of ultrahigh frequency DRG stimulation, as measured by VAS score compare to baseline VAS.</description>
        <time_frame>4 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrahigh Frequency Stimulation</title>
            <description>Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.&#xD;
GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (&gt;200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain Measured by Visual Analog Scale (VAS)</title>
          <description>VAS: 0 (no pain) to 10 (max pain). Change in pain as a result of ultrahigh frequency DRG stimulation, as measured by VAS score compare to baseline VAS.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Paresthesia</title>
        <description>If patients feel tingling during stimulation?</description>
        <time_frame>2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrahigh Frequency Stimulation</title>
            <description>Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.&#xD;
GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (&gt;200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Paresthesia</title>
          <description>If patients feel tingling during stimulation?</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pain Medication Consumption</title>
        <description>Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline</description>
        <time_frame>5 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ultrahigh Frequency Stimulation</title>
            <description>Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.&#xD;
GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (&gt;200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain Medication Consumption</title>
          <description>Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Trial duration (4 days)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ultrahigh Frequency Stimulation</title>
          <description>Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.&#xD;
GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (&gt;200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>procedural headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Increase blood pressure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Yeong-Ray Wen (Department of Anaesthesia)</name_or_title>
      <organization>China Medical University Hospital (in Taiwan)</organization>
      <phone>+886 4 2205-2121</phone>
      <email>yray.wen@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03285113
org study id: CTC1601
nct id: NCT03285113
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, single-arm, open label, single center pilot study to confirm the
      safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The
      actual trial length is 5 days. Pts will be given ultrahigh frequency pulse stimulation, and
      VAS will be obtained after 3-4 hours of each stimulation.
This study is a prospective, single-arm, open label, single center pilot study to confirm the
      safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The
      actual trial length is 5 days. An initial eligibility screening within Day -14. Pt admitted
      to hospital on Day 1. The lead implantation is conducted on Day 2, and the 1st treatment
      starts after anesthesia recovery (Day 2 T1). If VAS >4 at 4 hours after the 1st treatment,
      the 2nd treatment will be conducted. VAS will be acquired 4 hours after the 2nd treatment. On
      Day 3, physical examination and vital signs will be collected. If VAS >4, the 3rd treatment
      will be provided. One hour after the 3rd treatment, the device will be removed and an X-ray
      will be taken. Three hours after the removal, VAS will be collected and then the patient will
      be discharged. VAS will be estimated by phone call on Day 4, and the patient will return to
      OPD for follow up examination on Day 5. The trial is completed on Day 5 visit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE)
time frame: 5 days
description: Number of Participants with Adverse Events and Serious Adverse Events
measure: Change in Pain Measured by Visual Analog Scale (VAS)
time frame: 4 days
description: VAS: 0 (no pain) to 10 (max pain). Change in pain as a result of ultrahigh frequency DRG stimulation, as measured by VAS score compare to baseline VAS.
measure: Incidence of Paresthesia
time frame: 2 days
description: If patients feel tingling during stimulation?
measure: Change in Pain Medication Consumption
time frame: 5 days
description: Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline
arm group label: Ultrahigh Frequency Stimulation
arm group type: Experimental
description: Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG.
intervention type: Device
intervention name: GiMer Medical MN 1000 External Stimulator
description: Trial stimulator to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.
arm group label: Ultrahigh Frequency Stimulation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Complex Regional Pain Syndromes
mesh term: Reflex Sympathetic Dystrophy
mesh term: Syndrome
mesh term: Failed Back Surgery Syndrome
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 