<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/NCT03265249</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00084620</org_study_id>
    <nct_id>NCT03265249</nct_id>
  </id_info>
  <brief_title>BRIDGE Device for Post-operative Pain Control</brief_title>
  <acronym>BRIDGE</acronym>
  <official_title>Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) Using the BRIDGE Device for Post-Operative Pain Control in Patients Undergoing Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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>
      Auricular neurostimulation is a potential novel and non-invasive method of pain control&#xD;
      following liver transplantation in a growing patient population with the probability of&#xD;
      significant impact on economics and morbidity. The investigators propose a pilot study to&#xD;
      investigate the effects of auricular neurostimulation in patients receiving a liver&#xD;
      transplantation. The investigator will investigate the effects of auricular neurostimulation&#xD;
      with this novel device and compare it to the current standard of care for pain management&#xD;
      following liver transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized study to determine the efficacy of the BRIDGE device in&#xD;
      reducing pain and opioid use in patients following liver transplantation. Subjects will be&#xD;
      randomized in a 1:1 ration to one of the below groups:&#xD;
&#xD;
      Group 1: BRIDGE device will be placed prior to start of the surgery with standard of care&#xD;
      pain control analgesia&#xD;
&#xD;
      Group 2: Subjects will receive the standard of care pain control analgesia&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    slow enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">February 12, 2018</start_date>
  <completion_date type="Actual">April 3, 2020</completion_date>
  <primary_completion_date type="Actual">April 3, 2020</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>Two groups where randomization is either to device or SOC (standard of care)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)</measure>
    <time_frame>up to day 30</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Level</measure>
    <time_frame>up to day 30</time_frame>
    <description>Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response</measure>
    <time_frame>up to day 30</time_frame>
    <description>Determination of the intensity of nausea in the two groups (SOC and with device)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response</measure>
    <time_frame>up to day 30</time_frame>
    <description>Determination of the intensity of vomiting in the two groups (SOC and with device)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return.</measure>
    <time_frame>up to day 30</time_frame>
    <description>Evaluation of return of bowel function noting day of bowel movement occurrence in both groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Post-operative Ileus Will be Measured by Need for Nasogastric Decompression for &gt;48 Hours</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Determination of the presence of an ileus in the two groups (SOC and with device)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved Post-operative Mobility as Measured by the Patient Symptom Surveys</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Determination of mobility with in the two groups (SOC and with device)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in Length of Hospital Stay as Measured by Days in Hospital</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Determination of length of hospital stay with in the two groups (SOC and with device)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Liver Failure</condition>
  <condition>Liver Diseases, Alcoholic</condition>
  <condition>Liver Diseases</condition>
  <condition>Pain, Postoperative</condition>
  <condition>Transplant; Failure, Liver</condition>
  <condition>Liver Cirrhosis, Biliary</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will receive the standard of care pain control analgesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BRIDGE device</intervention_name>
    <description>an externally placed, FDA-cleared device that delivers percutaneous electrical stimulation with alternating frequencies to branches of cranial nerves (V, VII, IX, and X) through the external ear via a field effect</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria:&#xD;
&#xD;
               -  ≥18 years of age but &lt;70 years of age&#xD;
&#xD;
               -  Actively listed for isolated liver transplantation&#xD;
&#xD;
               -  Subject or legally authorized representative able to sign informed consent&#xD;
&#xD;
               -  Not currently treated with opioids or any medications that may interact with&#xD;
                  opioids&#xD;
&#xD;
               -  English speaking&#xD;
&#xD;
               -  Willing and able to participate and consent to this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of acute liver failure or primary sclerosing cholangitis (PSC)&#xD;
&#xD;
          -  Anticipated that the subject will require a new roux-en-y hepaticojejunostomy&#xD;
&#xD;
          -  Current use of opioid use or other substance abuse.&#xD;
&#xD;
          -  Chronic pain disorders&#xD;
&#xD;
          -  Need for regional anesthesia (regional nerve blocks or epidurals)&#xD;
&#xD;
          -  Adhesive allergy/sensitivity&#xD;
&#xD;
          -  Subject admitted to the ICU at the time of transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alicia Mavis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Universtity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <results_first_submitted>January 30, 2023</results_first_submitted>
  <results_first_submitted_qc>March 6, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 8, 2023</results_first_posted>
  <disposition_first_submitted>January 21, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>March 6, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 8, 2023</disposition_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 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>Liver Diseases</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Liver Failure</mesh_term>
    <mesh_term>Liver Cirrhosis, Biliary</mesh_term>
    <mesh_term>Liver Diseases, Alcoholic</mesh_term>
    <mesh_term>Pain, Postoperative</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>September 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT03265249/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>BRIDGE Device</title>
          <description>BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia&#xD;
BRIDGE device: an externally placed, FDA-cleared device that delivers percutaneous electrical stimulation with alternating frequencies to branches of cranial nerves (V, VII, IX, and X) through the external ear via a field effect</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>Subjects will receive the standard of care pain control analgesia</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>BRIDGE Device</title>
          <description>BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia&#xD;
BRIDGE device: an externally placed, FDA-cleared device that delivers percutaneous electrical stimulation with alternating frequencies to branches of cranial nerves (V, VII, IX, and X) through the external ear via a field effect</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>Subjects will receive the standard of care pain control analgesia</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="12"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="27"/>
          </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="56.81" spread="10.17"/>
                    <measurement group_id="B2" value="55.98" spread="10.57"/>
                    <measurement group_id="B3" value="56.40" spread="10.37"/>
                  </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="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="15"/>
                    <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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>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="12"/>
                    <measurement group_id="B2" value="15"/>
                    <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>Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)</title>
        <time_frame>up to day 30</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BRIDGE Device</title>
            <description>BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia&#xD;
BRIDGE device: an externally placed, FDA-cleared device that delivers percutaneous electrical stimulation with alternating frequencies to branches of cranial nerves (V, VII, IX, and X) through the external ear via a field effect</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Subjects will receive the standard of care pain control analgesia</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)</title>
          <units>milligrams morphine or equivalent (MEQ)</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.1" lower_limit="36.6" upper_limit="65.6"/>
                    <measurement group_id="O2" value="45.4" lower_limit="32.4" upper_limit="58.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.80</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>5.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.5</ci_lower_limit>
            <ci_upper_limit>29</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Level</title>
        <description>Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery</description>
        <time_frame>up to day 30</time_frame>
        <posting_date>09/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response</title>
        <description>Determination of the intensity of nausea in the two groups (SOC and with device)</description>
        <time_frame>up to day 30</time_frame>
        <posting_date>09/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response</title>
        <description>Determination of the intensity of vomiting in the two groups (SOC and with device)</description>
        <time_frame>up to day 30</time_frame>
        <posting_date>09/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return.</title>
        <description>Evaluation of return of bowel function noting day of bowel movement occurrence in both groups.</description>
        <time_frame>up to day 30</time_frame>
        <posting_date>09/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Post-operative Ileus Will be Measured by Need for Nasogastric Decompression for &gt;48 Hours</title>
        <description>Determination of the presence of an ileus in the two groups (SOC and with device)</description>
        <time_frame>up to 30 days</time_frame>
        <posting_date>09/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improved Post-operative Mobility as Measured by the Patient Symptom Surveys</title>
        <description>Determination of mobility with in the two groups (SOC and with device)</description>
        <time_frame>up to 30 days</time_frame>
        <posting_date>09/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction in Length of Hospital Stay as Measured by Days in Hospital</title>
        <description>Determination of length of hospital stay with in the two groups (SOC and with device)</description>
        <time_frame>up to 30 days</time_frame>
        <posting_date>09/2023</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>BRIDGE Device</title>
          <description>BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia&#xD;
BRIDGE device: an externally placed, FDA-cleared device that delivers percutaneous electrical stimulation with alternating frequencies to branches of cranial nerves (V, VII, IX, and X) through the external ear via a field effect</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>Subjects will receive the standard of care pain control analgesia</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="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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>
    <point_of_contact>
      <name_or_title>Alisha Mavis, M.D.</name_or_title>
      <organization>Duke University</organization>
      <phone>919-684-5068</phone>
      <email>alisha.mavis@duke.edu</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/NCT03265249
org study id: Pro00084620
nct id: NCT03265249
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Auricular neurostimulation is a potential novel and non-invasive method of pain control
      following liver transplantation in a growing patient population with the probability of
      significant impact on economics and morbidity. The investigators propose a pilot study to
      investigate the effects of auricular neurostimulation in patients receiving a liver
      transplantation. The investigator will investigate the effects of auricular neurostimulation
      with this novel device and compare it to the current standard of care for pain management
      following liver transplantation.
This is a prospective, randomized study to determine the efficacy of the BRIDGE device in
      reducing pain and opioid use in patients following liver transplantation. Subjects will be
      randomized in a 1:1 ration to one of the below groups:

      Group 1: BRIDGE device will be placed prior to start of the surgery with standard of care
      pain control analgesia

      Group 2: Subjects will receive the standard of care pain control analgesia
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups where randomization is either to device or SOC (standard of care)
primary purpose: Treatment
masking: None (Open Label)
measure: Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)
time frame: up to day 30
measure: Pain Level
time frame: up to day 30
description: Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery
measure: Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response
time frame: up to day 30
description: Determination of the intensity of nausea in the two groups (SOC and with device)
measure: Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response
time frame: up to day 30
description: Determination of the intensity of vomiting in the two groups (SOC and with device)
measure: Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return.
time frame: up to day 30
description: Evaluation of return of bowel function noting day of bowel movement occurrence in both groups.
measure: Incidence of Post-operative Ileus Will be Measured by Need for Nasogastric Decompression for >48 Hours
time frame: up to 30 days
description: Determination of the presence of an ileus in the two groups (SOC and with device)
measure: Improved Post-operative Mobility as Measured by the Patient Symptom Surveys
time frame: up to 30 days
description: Determination of mobility with in the two groups (SOC and with device)
measure: Reduction in Length of Hospital Stay as Measured by Days in Hospital
time frame: up to 30 days
description: Determination of length of hospital stay with in the two groups (SOC and with device)
arm group label: Group 1
arm group type: Experimental
description: BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia
arm group label: Group 2
arm group type: No Intervention
description: Subjects will receive the standard of care pain control analgesia
intervention type: Device
intervention name: BRIDGE device
description: an externally placed, FDA-cleared device that delivers percutaneous electrical stimulation with alternating frequencies to branches of cranial nerves (V, VII, IX, and X) through the external ear via a field effect
arm group label: Group 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Alicia Mavis, MD
role: Principal Investigator
affiliation: Duke Universtity
facility: 
country: United States
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Liver Cirrhosis
mesh term: Liver Failure
mesh term: Liver Cirrhosis, Biliary
mesh term: Liver Diseases, Alcoholic
mesh term: Pain, Postoperative
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 