<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/NCT04432727</url>
  </required_header>
  <id_info>
    <org_study_id>4090</org_study_id>
    <nct_id>NCT04432727</nct_id>
  </id_info>
  <brief_title>Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.</brief_title>
  <official_title>A Feasibility Study Evaluating the Impact Flexitouch Plus With Connectivity Has on Compliance in Patients With Breast Cancer-Related Lymphedema (BCRL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tactile Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tactile Medical</source>
  <oversight_info>
    <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>
      The objective of this study is to demonstrate the feasibility of using the Flexitouch Plus&#xD;
      with Cellular Connectivity (FT-CC) to monitor device use data to determine if reminders to&#xD;
      patients impact compliance, and to identify the impact device compliance has on arm girth,&#xD;
      quality of life (QOL), and symptom assessment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, on label, prospective, randomized, two-arm feasibility study that&#xD;
      plans to enroll 30 female subjects in the United States. In an effort to reduce potential&#xD;
      exposure to COVID-19, all study assessments are intended to be performed in a contactless&#xD;
      manner (i.e., telephone, video conference, etc). If a subject passes the initial screening&#xD;
      requirements via medical history and expresses interest in the study an informed consent form&#xD;
      will be provided to them. Once consent has been obtained they will undergo a baseline visit&#xD;
      where they will be randomized to one of two treatment groups: PASSIVE FT-CC (text messages&#xD;
      reminders will not be sent to subjects) and ACTIVE FT-CC (text messages reminders will be&#xD;
      sent if subject does not use the device for 2 consecutive days). Randomization was&#xD;
      incorporated into the study to determine if ACTIVE FT-CC affects device use. A total of 2&#xD;
      follow-up visits will be conducted over a 60-day period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Actual">November 19, 2021</completion_date>
  <primary_completion_date type="Actual">November 19, 2021</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>Compliance Measured as the Average Number of Treatments Per Week</measure>
    <time_frame>60 Days</time_frame>
    <description>Compare the rate of compliance in patients treated with PASSIVE FT-CC and ACTIVE FT-CC.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance With Device Use.</measure>
    <time_frame>Through 60 days after device training</time_frame>
    <description>Analysis of compliance with prescribed device use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment Via LYMQOL ARM</measure>
    <time_frame>Changes through 60 days after device training</time_frame>
    <description>Comparison of quality of life in patients treated with Active FT-CC vs. Passive FT-CC via Lymphedema Quality of Life Tool (LYMQOL ARM).&#xD;
Lymphedema Quality of Life Tool (LYMQOL-ARM) includes sub-scores for Function (range 10-40), Appearance (range 5-20), Symptoms (range 6-24), and Emotion (range 6-24) where lower scores represent a better outcome. It also includes an Overall QOL sub-score (range 0-10) where a higher score represents a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment Via SF-36 Physical Functioning Domain Score</measure>
    <time_frame>Changes through 60 days after device training</time_frame>
    <description>Comparison of baseline vs. 60-day follow-up results of the The RAND 36-Item Short Form Survey (SF-36).&#xD;
The RAND 36-Item Short Form Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item for perceived change in health. Min value: 0, Max value: 100. Higher scores represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment Via LSIDS-A Score</measure>
    <time_frame>Changes through 60 days after device training</time_frame>
    <description>Comparison of baseline vs. 60-day follow-up results of the LSIDS-A Scoring Tool.&#xD;
The LSIDS-A domains consist of 30 questions in the areas of soft tissue sensation, neurological sensation, function, behavior, resource, sexuality, and activity. Scores are compiled by domain and overall. Overall results will be posted here.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Breast Cancer Lymphedema</condition>
  <arm_group>
    <arm_group_label>ACTIVE FT-CC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Text message reminders will be sent if subject does not use the device for 2 consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PASSIVE FT-CC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Text message reminders will not be sent to subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Flexitouch Plus with Cellular Connectivity (FT-CC)</intervention_name>
    <description>Daily use of FT-CC</description>
    <arm_group_label>ACTIVE FT-CC</arm_group_label>
    <arm_group_label>PASSIVE FT-CC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female 18 years of age or older&#xD;
&#xD;
          2. Diagnosis of unilateral breast cancer-related lymphedema&#xD;
&#xD;
          3. Willing and able to give informed consent (remotely or in person)&#xD;
&#xD;
          4. Willing and able to comply with the study protocol requirements and all study-related&#xD;
             visit requirements, including the ability to participate remotely&#xD;
&#xD;
          5. Willing and able to receive text messages from sponsor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. In-home use of PCD within previous 3 months&#xD;
&#xD;
          2. Phase-one CDT within previous 1 month or planned phase-one CDT during study&#xD;
             participation Phase-one CDT defined as professionally administered MLD and/or&#xD;
             multi-layer short stretch compressive bandaging.&#xD;
&#xD;
          3. Inability to be fit for PCD garments&#xD;
&#xD;
          4. Heart failure (acute pulmonary edema, decompensated acute heart failure)&#xD;
&#xD;
          5. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute&#xD;
             pulmonary embolism)&#xD;
&#xD;
          6. Active skin or limb infection/inflammatory disease (acute cellulitis, other&#xD;
             uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk&#xD;
&#xD;
          7. Currently receiving treatment for cancer with curative intent.&#xD;
&#xD;
          8. Any circumstance where increased lymphatic or venous return is undesirable&#xD;
&#xD;
          9. Currently pregnant or trying to become pregnant&#xD;
&#xD;
         10. Known inability to receive cell phone connection where FT-CC therapy will be&#xD;
             administered&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Pesek, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Peter's Health Partners</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicolas Ajkay, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Louisville</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Peter's Hospital</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samaritan Hospital Hildegard Medicus Cancer Center</name>
      <address>
        <city>Troy</city>
        <state>New York</state>
        <zip>12180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <results_first_submitted>February 6, 2023</results_first_submitted>
  <results_first_submitted_qc>May 23, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 24, 2023</results_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 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>Breast Neoplasms</mesh_term>
    <mesh_term>Lymphedema</mesh_term>
    <mesh_term>Breast Cancer Lymphedema</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 11, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT04432727/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ACTIVE FT-CC</title>
          <description>Text message reminders will be sent if subject does not use the device for 2 consecutive days.&#xD;
Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC</description>
        </group>
        <group group_id="P2">
          <title>PASSIVE FT-CC</title>
          <description>Text message reminders will not be sent to subjects.&#xD;
Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ACTIVE FT-CC</title>
          <description>Text message reminders will be sent if subject does not use the device for 2 consecutive days.&#xD;
Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC</description>
        </group>
        <group group_id="B2">
          <title>PASSIVE FT-CC</title>
          <description>Text message reminders will not be sent to subjects.&#xD;
Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="29"/>
          </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="52.3" spread="10.8"/>
                    <measurement group_id="B2" value="57.7" spread="9.7"/>
                    <measurement group_id="B3" value="54.9" spread="10.4"/>
                  </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="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="190.9" spread="42.8"/>
                    <measurement group_id="B2" value="179.1" spread="42.0"/>
                    <measurement group_id="B3" value="185.2" spread="42.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.8" spread="2.3"/>
                    <measurement group_id="B2" value="62.4" spread="1.6"/>
                    <measurement group_id="B3" value="63.1" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.1" spread="8.0"/>
                    <measurement group_id="B2" value="32.4" spread="7.4"/>
                    <measurement group_id="B3" value="32.8" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dominant Hand</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Left</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Right</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Compliance Measured as the Average Number of Treatments Per Week</title>
        <description>Compare the rate of compliance in patients treated with PASSIVE FT-CC and ACTIVE FT-CC.</description>
        <time_frame>60 Days</time_frame>
        <population>Patients who received text reminders vs. those that did not.</population>
        <group_list>
          <group group_id="O1">
            <title>ACTIVE FT-CC</title>
            <description>Text message reminders will be sent if subject does not use the device for 2 consecutive days.&#xD;
Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC</description>
          </group>
          <group group_id="O2">
            <title>PASSIVE FT-CC</title>
            <description>Text message reminders will not be sent to subjects.&#xD;
Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC</description>
          </group>
        </group_list>
        <measure>
          <title>Compliance Measured as the Average Number of Treatments Per Week</title>
          <description>Compare the rate of compliance in patients treated with PASSIVE FT-CC and ACTIVE FT-CC.</description>
          <population>Patients who received text reminders vs. those that did not.</population>
          <units>treatments/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="1.8"/>
                    <measurement group_id="O2" value="5.2" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Compliance With Device Use.</title>
        <description>Analysis of compliance with prescribed device use.</description>
        <time_frame>Through 60 days after device training</time_frame>
        <population>Subjects who were also seen 60 days post randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>ACTIVE FT-CC</title>
            <description>Text message reminders were sent if the subject did not use the device for 2 consecutive days. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC</description>
          </group>
          <group group_id="O2">
            <title>PASSIVE FT-CC</title>
            <description>Text message reminders were not sent to subjects. Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC</description>
          </group>
        </group_list>
        <measure>
          <title>Compliance With Device Use.</title>
          <description>Analysis of compliance with prescribed device use.</description>
          <population>Subjects who were also seen 60 days post randomization.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Non-Compliant (&lt;1 Day / Week)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partially Compliant (1-4 Days / Week)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Compliant (5-7 Days / Week)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Assessment Via LYMQOL ARM</title>
        <description>Comparison of quality of life in patients treated with Active FT-CC vs. Passive FT-CC via Lymphedema Quality of Life Tool (LYMQOL ARM).&#xD;
Lymphedema Quality of Life Tool (LYMQOL-ARM) includes sub-scores for Function (range 10-40), Appearance (range 5-20), Symptoms (range 6-24), and Emotion (range 6-24) where lower scores represent a better outcome. It also includes an Overall QOL sub-score (range 0-10) where a higher score represents a better outcome.</description>
        <time_frame>Changes through 60 days after device training</time_frame>
        <population>Subjects completing the LYMQOL-ARM Tool at 60 days overall quality of life score 0-10 scale.</population>
        <group_list>
          <group group_id="O1">
            <title>Active FT-CC</title>
            <description>Subjects receiving text message reminders when device has not been used for 2 days.</description>
          </group>
          <group group_id="O2">
            <title>Passive FT-CC</title>
            <description>Subjects did not receive text reminders when device was not used.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Assessment Via LYMQOL ARM</title>
          <description>Comparison of quality of life in patients treated with Active FT-CC vs. Passive FT-CC via Lymphedema Quality of Life Tool (LYMQOL ARM).&#xD;
Lymphedema Quality of Life Tool (LYMQOL-ARM) includes sub-scores for Function (range 10-40), Appearance (range 5-20), Symptoms (range 6-24), and Emotion (range 6-24) where lower scores represent a better outcome. It also includes an Overall QOL sub-score (range 0-10) where a higher score represents a better outcome.</description>
          <population>Subjects completing the LYMQOL-ARM Tool at 60 days overall quality of life score 0-10 scale.</population>
          <units>score 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="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="2.0"/>
                    <measurement group_id="O2" value="6.6" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Assessment Via SF-36 Physical Functioning Domain Score</title>
        <description>Comparison of baseline vs. 60-day follow-up results of the The RAND 36-Item Short Form Survey (SF-36).&#xD;
The RAND 36-Item Short Form Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item for perceived change in health. Min value: 0, Max value: 100. Higher scores represent a better outcome.</description>
        <time_frame>Changes through 60 days after device training</time_frame>
        <population>Patients with data through 60 days after device training. An increase in score reflects a positive outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Active FT-CC</title>
            <description>Subjects receiving text message reminders when device has not been used for 2 days.</description>
          </group>
          <group group_id="O2">
            <title>Passive FT-CC</title>
            <description>Subjects did not receive text reminders when device was not used.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Assessment Via SF-36 Physical Functioning Domain Score</title>
          <description>Comparison of baseline vs. 60-day follow-up results of the The RAND 36-Item Short Form Survey (SF-36).&#xD;
The RAND 36-Item Short Form Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item for perceived change in health. Min value: 0, Max value: 100. Higher scores represent a better outcome.</description>
          <population>Patients with data through 60 days after device training. An increase in score reflects a positive outcome.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Decrease in general health domain scores at 60 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change in general health domain scores at 60 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in general health domain score change at 60 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life Assessment Via LSIDS-A Score</title>
        <description>Comparison of baseline vs. 60-day follow-up results of the LSIDS-A Scoring Tool.&#xD;
The LSIDS-A domains consist of 30 questions in the areas of soft tissue sensation, neurological sensation, function, behavior, resource, sexuality, and activity. Scores are compiled by domain and overall. Overall results will be posted here.</description>
        <time_frame>Changes through 60 days after device training</time_frame>
        <population>All patients with follow-up through 60 days completing the LSIDS-A Questionnaire. A reduction in overall domain score change is considered to be positive.</population>
        <group_list>
          <group group_id="O1">
            <title>Active FT-CC</title>
            <description>Subjects receiving text message reminders when device has not been used for 2 days.</description>
          </group>
          <group group_id="O2">
            <title>Passive FT-CC</title>
            <description>Subjects did not receive text reminders when device was not used.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Assessment Via LSIDS-A Score</title>
          <description>Comparison of baseline vs. 60-day follow-up results of the LSIDS-A Scoring Tool.&#xD;
The LSIDS-A domains consist of 30 questions in the areas of soft tissue sensation, neurological sensation, function, behavior, resource, sexuality, and activity. Scores are compiled by domain and overall. Overall results will be posted here.</description>
          <population>All patients with follow-up through 60 days completing the LSIDS-A Questionnaire. A reduction in overall domain score change is considered to be positive.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Decrease in domain score change at 60 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change in domain score at 60 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in domain score change at 60 days.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from the point of randomization through study exit (Day 60).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ACTIVE FT-CC</title>
          <description>Text message reminders will be sent if subject does not use the device for 2 consecutive days.&#xD;
Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC</description>
        </group>
        <group group_id="E2">
          <title>PASSIVE FT-CC</title>
          <description>Text message reminders will not be sent to subjects.&#xD;
Flexitouch Plus with Cellular Connectivity (FT-CC): Daily use of FT-CC</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </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="4" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphedema exacerbation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Progressive disease right axilla</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Worsening lymphedema (mild)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Suspected cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Sinus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Trauma secondary to fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Clicking in right thumb joint</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Bilateral buttock pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Exacerbation of lymphedema related pain right arm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Increased lung nodule from 2011</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Swelling under right arm due to weight gain, no lymphedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Tender in armpit when using device</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Maculo-papular rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The COVID-19 pandemic resulted in the closure of several clinics and when clinics were able to resume operations, it was on a limited basis to keep patients and providers physically distanced from others. In addition, reduction of staff impacted research conduct. Finally, patients were often not willing to attend study visits. These factors all contributed to slow enrollment and a high early withdrawal rate which led to the decision to discontinue the study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Michelle Wetherby</name_or_title>
      <organization>Tactile Medical</organization>
      <phone>612-230-4576</phone>
      <email>mwetherby@tactilemedical.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/NCT04432727
org study id: 4090
nct id: NCT04432727
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The objective of this study is to demonstrate the feasibility of using the Flexitouch Plus
      with Cellular Connectivity (FT-CC) to monitor device use data to determine if reminders to
      patients impact compliance, and to identify the impact device compliance has on arm girth,
      quality of life (QOL), and symptom assessment.
This is a multi-center, on label, prospective, randomized, two-arm feasibility study that
      plans to enroll 30 female subjects in the United States. In an effort to reduce potential
      exposure to COVID-19, all study assessments are intended to be performed in a contactless
      manner (i.e., telephone, video conference, etc). If a subject passes the initial screening
      requirements via medical history and expresses interest in the study an informed consent form
      will be provided to them. Once consent has been obtained they will undergo a baseline visit
      where they will be randomized to one of two treatment groups: PASSIVE FT-CC (text messages
      reminders will not be sent to subjects) and ACTIVE FT-CC (text messages reminders will be
      sent if subject does not use the device for 2 consecutive days). Randomization was
      incorporated into the study to determine if ACTIVE FT-CC affects device use. A total of 2
      follow-up visits will be conducted over a 60-day period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Compliance Measured as the Average Number of Treatments Per Week
time frame: 60 Days
description: Compare the rate of compliance in patients treated with PASSIVE FT-CC and ACTIVE FT-CC.
measure: Compliance With Device Use.
time frame: Through 60 days after device training
description: Analysis of compliance with prescribed device use.
measure: Quality of Life Assessment Via LYMQOL ARM
time frame: Changes through 60 days after device training
description: Comparison of quality of life in patients treated with Active FT-CC vs. Passive FT-CC via Lymphedema Quality of Life Tool (LYMQOL ARM).
Lymphedema Quality of Life Tool (LYMQOL-ARM) includes sub-scores for Function (range 10-40), Appearance (range 5-20), Symptoms (range 6-24), and Emotion (range 6-24) where lower scores represent a better outcome. It also includes an Overall QOL sub-score (range 0-10) where a higher score represents a better outcome.
measure: Quality of Life Assessment Via SF-36 Physical Functioning Domain Score
time frame: Changes through 60 days after device training
description: Comparison of baseline vs. 60-day follow-up results of the The RAND 36-Item Short Form Survey (SF-36).
The RAND 36-Item Short Form Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item for perceived change in health. Min value: 0, Max value: 100. Higher scores represent a better outcome.
measure: Quality of Life Assessment Via LSIDS-A Score
time frame: Changes through 60 days after device training
description: Comparison of baseline vs. 60-day follow-up results of the LSIDS-A Scoring Tool.
The LSIDS-A domains consist of 30 questions in the areas of soft tissue sensation, neurological sensation, function, behavior, resource, sexuality, and activity. Scores are compiled by domain and overall. Overall results will be posted here.
arm group label: ACTIVE FT-CC
arm group type: Experimental
description: Text message reminders will be sent if subject does not use the device for 2 consecutive days.
arm group label: PASSIVE FT-CC
arm group type: Experimental
description: Text message reminders will not be sent to subjects.
intervention type: Device
intervention name: Flexitouch Plus with Cellular Connectivity (FT-CC)
description: Daily use of FT-CC
arm group label: ACTIVE FT-CC
arm group label: PASSIVE FT-CC
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarah Pesek, MD
role: Principal Investigator
affiliation: St. Peter's Health Partners
last name: Nicolas Ajkay, MD
role: Principal Investigator
affiliation: University of Louisville
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Lymphedema
mesh term: Breast Cancer Lymphedema
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The COVID-19 pandemic resulted in the closure of several clinics and when clinics were able to resume operations, it was on a limited basis to keep patients and providers physically distanced from others. In addition, reduction of staff impacted research conduct. Finally, patients were often not willing to attend study visits. These factors all contributed to slow enrollment and a high early withdrawal rate which led to the decision to discontinue the study.
point of contact: 