<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/NCT03299881</url>
  </required_header>
  <id_info>
    <org_study_id>CD-004</org_study_id>
    <nct_id>NCT03299881</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss</brief_title>
  <official_title>Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elira Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Elira Therapeutics, Inc.</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 study is a randomized, adaptive, parallel arm study. The treatment group will receive&#xD;
      the Elira wearable patch system and provided instructions for use and advised to follow a&#xD;
      1200 calorie diet. The control group will be asked to follow a 12 calorie diet only. Each&#xD;
      group will be followed for 12 weeks. Total body weight loss will be measured as well as&#xD;
      appetite changes. Safety data will be collected throughout the study period. Safety and&#xD;
      effectiveness will be determined based on differences between the groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study employs a randomized, adaptive, parallel arm study in which, cohorts of enrolled&#xD;
      subjects (25 per arm) are assessed for dose response and progression to achievement of&#xD;
      primary and secondary endpoints. Enrollment will be up to 300 subjects at 4 US centers.&#xD;
&#xD;
      After signing informed consent, subjects will be screened during a one week&#xD;
      screening/baseline period to determine if they meet the inclusion criteria and exhibit none&#xD;
      of the exclusion criteria. Weight, blood pressure, blood lipids, HgA1c, pregnancy test (for&#xD;
      women of childbearing age), and patient questionnaires will be collected. If eligible,&#xD;
      subjects will be randomized to treatment or control groups. The treatment group will receive&#xD;
      training on the Elira Wearable Patch System and the first TENS session will be administered&#xD;
      in the investigators office. Both groups will receive an electronic scale and instructions on&#xD;
      1200 calorie diet as well as diary completion requirements to be completed throughout the&#xD;
      study. All subjects will be required to have in office follow-up visits every 4 weeks for 12&#xD;
      weeks. Up to 2 additional follow-up visits will be permitted within that 12 week time period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Early termination due to technical problems with the device.&#xD;
  </why_stopped>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</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>
    <intervention_model_description>Randomized, adaptive parallel arm study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Emergent Adverse Events</measure>
    <time_frame>12 weeks</time_frame>
    <description>Safety/Tolerability will be assessed by the non-inferiority of incidence of serious adverse events (SAEs), unanticipated DAEs (USAEs), device-related SAEs (DSAEs), and unanticipated device-related SAEs (UDAEs) that are associated with the TENS therapy throughout the stimulation and the follow-up period versus historical control (compared with other TENS systems).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcutaneous Nerve Stimulator (TENS)</intervention_name>
    <description>The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diet &amp; Exercise</intervention_name>
    <description>Subjects to be instructed on a healthy 1200 calorie diet.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is between 18 - 65 years of age inclusive.&#xD;
&#xD;
          2. Subject has a BMI of 25-35 kg/ m^2 inclusive.&#xD;
&#xD;
          3. Subject has signed the informed consent form and is able to comply with study protocol&#xD;
             and adhere to study visit schedule.&#xD;
&#xD;
          4. Subject is able to wear and use a wearable, patch TENS system.&#xD;
&#xD;
          5. Subject is able to use a touch screen hand held smart phone.&#xD;
&#xD;
          6. Subject is fluent in English and can complete patient questionnaires.&#xD;
&#xD;
          7. Subject can comply with a 1200 calorie the recommended diet for the duration of the&#xD;
             study.&#xD;
&#xD;
          8. Subject is male or non-pregnant, non-lactating female, who agrees to use effective&#xD;
             contraceptive methods throughout the length of the trial based on PI approval.&#xD;
&#xD;
          9. Females of childbearing potential must have a negative urine pregnancy test at&#xD;
             enrollment visit, prior to placement of ELIRA device.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Subject has any known gastrointestinal disorder that in the opinion of the PI&#xD;
             precludes enrollment into the trial.&#xD;
&#xD;
          2. Subject has had a prior bariatric procedure.&#xD;
&#xD;
          3. Subject has any significant multisystem disease in the opinion of the PI.&#xD;
&#xD;
          4. Subject has &gt; 6.5 HbA1c.&#xD;
&#xD;
          5. Subject has significant cardiac arrhythmia, ectopy, or significant cardiovascular&#xD;
             disease.&#xD;
&#xD;
          6. Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).&#xD;
&#xD;
          7. Subject is a female of child-bearing potential who is pregnant or intends to become&#xD;
             pregnant during the trial.&#xD;
&#xD;
          8. Subject has a history of any malignancy in the last 2 years.&#xD;
&#xD;
          9. Subject has had a weight change of + 5% of his/her Total Body Weight in the 3 months&#xD;
             prior to enrollment.&#xD;
&#xD;
         10. Subject has a moderate / severe psychiatric disorder.&#xD;
&#xD;
         11. Subject has a diagnosed neurological disease.&#xD;
&#xD;
         12. Subject has a diagnosed eating disorder.&#xD;
&#xD;
         13. Subject has a skin disorder affecting the thoracic dermatomes.&#xD;
&#xD;
         14. Subject has abdominal surgery or other scars which may interfere with stimulation in&#xD;
             the opinion of the PI.&#xD;
&#xD;
         15. Subject is currently enrolled in other, potentially confounding research.&#xD;
&#xD;
         16. Subject has known allergic reaction to materials in the electrodes and/or is otherwise&#xD;
             unable to tolerate stimulation with the wearable TENS system.&#xD;
&#xD;
         17. Subject is actively participating or unwilling to discontinue participation in another&#xD;
             weight loss program.&#xD;
&#xD;
         18. Subject is taking weight loss control medications including but not limited to OTC&#xD;
             medications, Metformin, and Belviq.&#xD;
&#xD;
         19. Subject is unable to take anti-nausea medications planned for the study.&#xD;
&#xD;
         20. Inability to walk at least 0.8 kilometers per day (10 minutes of continuous walking).&#xD;
&#xD;
         21. Current smoker or user of nicotine product or smoking cessation within 1 year of the&#xD;
             screening date.&#xD;
&#xD;
         22. History of treatment for or current abuse of drugs or alcohol.&#xD;
&#xD;
         23. A score of ≥10 on the Patient Health Questionnaire 9 (PHQ-9), demonstrating moderate&#xD;
             depression.&#xD;
&#xD;
         24. Any subject that the investigator considers inappropriate for the study for medical&#xD;
             reasons.&#xD;
&#xD;
         25. Subject has a history of migraine and/or is taking Topiramate for severe headache&#xD;
             disorders.&#xD;
&#xD;
         26. Subject is on hormonal or other drug therapy which may alter antral motility or&#xD;
             appetite, per physician discretion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shelby Sullivan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Louis Women's Healthcare Group</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <results_first_submitted>September 15, 2021</results_first_submitted>
  <results_first_submitted_qc>October 13, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 10, 2021</results_first_posted>
  <last_update_submitted>October 13, 2021</last_update_submitted>
  <last_update_submitted_qc>October 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 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>Overweight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>September 25, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03299881/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment</title>
          <description>The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.&#xD;
Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.&#xD;
Diet &amp; Exercise: Subjects to be instructed on a healthy 1200 calorie diet.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.&#xD;
Diet &amp; Exercise: Subjects to be instructed on a healthy 1200 calorie diet.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Termination</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment</title>
          <description>The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.&#xD;
Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.&#xD;
Diet &amp; Exercise: Subjects to be instructed on a healthy 1200 calorie diet.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.&#xD;
Diet &amp; Exercise: Subjects to be instructed on a healthy 1200 calorie diet.</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="39"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="77"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.2" lower_limit="28" upper_limit="65"/>
                    <measurement group_id="B2" value="46.5" lower_limit="19" upper_limit="64"/>
                    <measurement group_id="B3" value="47.4" lower_limit="19" upper_limit="65"/>
                  </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="39"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>Black</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="36"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.9" lower_limit="26.3" upper_limit="34.5"/>
                    <measurement group_id="B2" value="29.2" lower_limit="25.4" upper_limit="34.5"/>
                    <measurement group_id="B3" value="29.6" lower_limit="25.4" upper_limit="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="178.5" lower_limit="142.6" upper_limit="220.2"/>
                    <measurement group_id="B2" value="174.6" lower_limit="149.4" upper_limit="200.2"/>
                    <measurement group_id="B3" value="176.6" lower_limit="142.6" upper_limit="220.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Treatment Emergent Adverse Events</title>
        <description>Safety/Tolerability will be assessed by the non-inferiority of incidence of serious adverse events (SAEs), unanticipated DAEs (USAEs), device-related SAEs (DSAEs), and unanticipated device-related SAEs (UDAEs) that are associated with the TENS therapy throughout the stimulation and the follow-up period versus historical control (compared with other TENS systems).</description>
        <time_frame>12 weeks</time_frame>
        <population>Study was terminated and recruitment was stopped. Sincere efforts were made but technical difficulties with device prevented the necessary data collection to allow specified outcome analysis. Adverse event data is reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.&#xD;
Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.&#xD;
Diet &amp; Exercise: Subjects to be instructed on a healthy 1200 calorie diet.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.&#xD;
Diet &amp; Exercise: Subjects to be instructed on a healthy 1200 calorie diet.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Emergent Adverse Events</title>
          <description>Safety/Tolerability will be assessed by the non-inferiority of incidence of serious adverse events (SAEs), unanticipated DAEs (USAEs), device-related SAEs (DSAEs), and unanticipated device-related SAEs (UDAEs) that are associated with the TENS therapy throughout the stimulation and the follow-up period versus historical control (compared with other TENS systems).</description>
          <population>Study was terminated and recruitment was stopped. Sincere efforts were made but technical difficulties with device prevented the necessary data collection to allow specified outcome analysis. Adverse event data is reported.</population>
          <units>Serious Adverse Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment</title>
          <description>The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.&#xD;
Transcutaneous Nerve Stimulator (TENS): The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.&#xD;
Diet &amp; Exercise: Subjects to be instructed on a healthy 1200 calorie diet.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.&#xD;
Diet &amp; Exercise: Subjects to be instructed on a healthy 1200 calorie diet.</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="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="39" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Vomitting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Cracked tooth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Torn rotator cuff</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Elbow pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Swelling, upper extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Left knee pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Venous thoracic outlet syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Intraductal papilloma mass, left breast</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Bartholin's gland abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Asthma exacerbation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Strep throat</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Contact dermatitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Blistering rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Worsening contact dermatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Body rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Poison ivy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>Early termination due to technical problems with the device. Insufficient data to produce statistically reliable results.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Stephanie Amlung, PhD, RN, Vice President, Clinical Affairs</name_or_title>
      <organization>Elira Therapeutics, Inc.</organization>
      <phone>513-236-6799</phone>
      <email>samlung@elira.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/NCT03299881
org study id: CD-004
nct id: NCT03299881
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study is a randomized, adaptive, parallel arm study. The treatment group will receive
      the Elira wearable patch system and provided instructions for use and advised to follow a
      1200 calorie diet. The control group will be asked to follow a 12 calorie diet only. Each
      group will be followed for 12 weeks. Total body weight loss will be measured as well as
      appetite changes. Safety data will be collected throughout the study period. Safety and
      effectiveness will be determined based on differences between the groups.
This study employs a randomized, adaptive, parallel arm study in which, cohorts of enrolled
      subjects (25 per arm) are assessed for dose response and progression to achievement of
      primary and secondary endpoints. Enrollment will be up to 300 subjects at 4 US centers.

      After signing informed consent, subjects will be screened during a one week
      screening/baseline period to determine if they meet the inclusion criteria and exhibit none
      of the exclusion criteria. Weight, blood pressure, blood lipids, HgA1c, pregnancy test (for
      women of childbearing age), and patient questionnaires will be collected. If eligible,
      subjects will be randomized to treatment or control groups. The treatment group will receive
      training on the Elira Wearable Patch System and the first TENS session will be administered
      in the investigators office. Both groups will receive an electronic scale and instructions on
      1200 calorie diet as well as diary completion requirements to be completed throughout the
      study. All subjects will be required to have in office follow-up visits every 4 weeks for 12
      weeks. Up to 2 additional follow-up visits will be permitted within that 12 week time period.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, adaptive parallel arm study
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment Emergent Adverse Events
time frame: 12 weeks
description: Safety/Tolerability will be assessed by the non-inferiority of incidence of serious adverse events (SAEs), unanticipated DAEs (USAEs), device-related SAEs (DSAEs), and unanticipated device-related SAEs (UDAEs) that are associated with the TENS therapy throughout the stimulation and the follow-up period versus historical control (compared with other TENS systems).
arm group label: Treatment
arm group type: Experimental
description: The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatone for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite.
arm group label: Control
arm group type: Active Comparator
description: Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite.
intervention type: Device
intervention name: Transcutaneous Nerve Stimulator (TENS)
description: The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.
arm group label: Treatment
intervention type: Behavioral
intervention name: Diet & Exercise
description: Subjects to be instructed on a healthy 1200 calorie diet.
arm group label: Control
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Shelby Sullivan, MD
role: Principal Investigator
affiliation: Consultant
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
mesh term: Weight Loss
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination due to technical problems with the device. Insufficient data to produce statistically reliable results.
point of contact: 