<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/NCT03266094</url>
  </required_header>
  <id_info>
    <org_study_id>MDT17024BZP</org_study_id>
    <nct_id>NCT03266094</nct_id>
  </id_info>
  <brief_title>A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy</brief_title>
  <official_title>A Prospective, Multi-center, Single Arm Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic - MITG</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess safety and performance with the use of the BiZact™&#xD;
      device in tonsillectomy procedures in children and adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, multi-center, single arm, study of BiZact™ on children and adolescents&#xD;
      undergoing tonsillectomy.&#xD;
&#xD;
      Study Visits:&#xD;
&#xD;
        -  Screening/Baseline&#xD;
&#xD;
        -  Surgery, Day 0&#xD;
&#xD;
        -  Post-Op Follow-up Day 1 - Day 7, Day 10, &amp; Day 14 (Home assessments)&#xD;
&#xD;
        -  Post-Op Follow-up Day 28 (Office Visit)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2018</start_date>
  <completion_date type="Actual">July 11, 2019</completion_date>
  <primary_completion_date type="Actual">June 21, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intra-operative Blood Loss</measure>
    <time_frame>During procedure</time_frame>
    <description>The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients With Intra-operative Blood Loss</measure>
    <time_frame>During procedure</time_frame>
    <description>The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device</measure>
    <time_frame>During Procedure</time_frame>
    <description>Ability to dissect tonsils with investigational device via Likert Scale (Very Good, Good, Acceptable, Poor, Very Poor).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)</measure>
    <time_frame>During Procedure</time_frame>
    <description>Ability to achieve hemostasis (arrest of bleeding, as assessed by visual inspection of the Investigator) without the use of other interventions (e.g. energy device or sutures)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>&quot;Number of Cases/Participants With Analgesic Consumption</measure>
    <time_frame>28 days post-operatively</time_frame>
    <description>Analgesic consumption (standard of care) and concomitant medications (via patient diary).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain</measure>
    <time_frame>Post-operative Day 4</time_frame>
    <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain</measure>
    <time_frame>Post-operative Day 5</time_frame>
    <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain</measure>
    <time_frame>Post-operative Day 6</time_frame>
    <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain</measure>
    <time_frame>Post-operative Day 7</time_frame>
    <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain</measure>
    <time_frame>Post-operative Day 10</time_frame>
    <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain</measure>
    <time_frame>Post-operative Day 14</time_frame>
    <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain</measure>
    <time_frame>Post-operative Day 28</time_frame>
    <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain</measure>
    <time_frame>Day 1</time_frame>
    <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain</measure>
    <time_frame>Day 2</time_frame>
    <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain</measure>
    <time_frame>Day 3</time_frame>
    <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Tonsillectomy</condition>
  <arm_group>
    <arm_group_label>A bipolar instrument for tonsillectomies</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A bipolar electrosurgical device that employs Radio frequency (RF) energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BiZact™: A bipolar instrument for tonsillectomies</intervention_name>
    <description>A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.</description>
    <arm_group_label>A bipolar instrument for tonsillectomies</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children and adolescent subjects 2-12 years of age at the time of the procedure,&#xD;
             inclusive&#xD;
&#xD;
          2. Scheduled to undergo tonsillectomy&#xD;
&#xD;
          3. The subject and subject's Legally Authorized Representative (LAR) is willing to&#xD;
             participate and consents to participate, as documented by signed informed consent form&#xD;
             and/ or assent form (as applicable)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects undergoing:&#xD;
&#xD;
               1. Tonsillectomy as a result of cancer&#xD;
&#xD;
               2. Unilateral tonsillectomy&#xD;
&#xD;
          2. Subjects with:&#xD;
&#xD;
               1. Known Bleeding disorders&#xD;
&#xD;
               2. History of peritonsillar abscess&#xD;
&#xD;
               3. Craniofacial disorders&#xD;
&#xD;
               4. Down's syndrome (Trisomy 21)&#xD;
&#xD;
               5. Cerebral palsy&#xD;
&#xD;
               6. Major heart disease (including but not limited to; right-sided heart failure,&#xD;
                  left-sided heart failure, congestive heart failure, coronary artery disease,&#xD;
                  arrhythmias, chronic heart failure, acute heart failure, etc.)&#xD;
&#xD;
               7. Current tobacco use&#xD;
&#xD;
          3. Subjects unable to comply with the required study follow-up visits&#xD;
&#xD;
          4. Female subjects pregnant at time of procedure&#xD;
&#xD;
          5. The subject has comorbidities which, in the opinion of the Investigator, will not be&#xD;
             appropriate for the study or the subject has an estimated life expectancy of less than&#xD;
             6 months.&#xD;
&#xD;
          6. The subject is participating or has participated in any drug or device research study&#xD;
             within 30 days of enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eugene Brown, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Coastal Pediatric Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southeast Clinical Research Associates, LLC</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Pediatric Associates</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Australia</country>
  </removed_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <results_first_submitted>March 28, 2020</results_first_submitted>
  <results_first_submitted_qc>April 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2020</results_first_posted>
  <last_update_submitted>May 12, 2020</last_update_submitted>
  <last_update_submitted_qc>May 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>March 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03266094/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 60 children, ages 2 to 12 in the US, were enrolled into a single-arm trial. A total of 60 subjects were screened and consented.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>BiZact Arm</title>
          <description>A bipolar electrosurgical device that employs Radio frequency (RF) energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>During the study, 60 patients were screened, and 60 patients were consented and enrolled in the study. One patient was lost to follow-up. Another patient withdrew from the study during post-procedure follow-up. Both patients were still included in the intent-to-treat data analysis with the data obtained.</population>
      <group_list>
        <group group_id="B1">
          <title>BiZact Arm</title>
          <description>60 Pediatric subjects undergoing tonsillectomy</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="6.7" spread="2.63"/>
                  </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="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <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="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Undergoing Tonsillectomy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Signed Informed Consent</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Intra-operative Blood Loss</title>
        <description>The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis</description>
        <time_frame>During procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>A Bipolar Instrument for Tonsillectomies</title>
            <description>A bipolar electrosurgical device that employs Radio frequency (RF) energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.&#xD;
BiZact™: A bipolar instrument for tonsillectomies: A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.</description>
          </group>
        </group_list>
        <measure>
          <title>Intra-operative Blood Loss</title>
          <description>The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis</description>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="2.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Intra-operative Blood Loss</title>
        <description>The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis</description>
        <time_frame>During procedure</time_frame>
        <population>Intra-operative bleeding occurred in 29 of the 60 patients. For subjects with no intra-operative bleeding, volume was considered as 0 mL.</population>
        <group_list>
          <group group_id="O1">
            <title>A Bipolar Instrument for Tonsillectomies</title>
            <description>A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.&#xD;
BiZact™: A bipolar instrument for tonsillectomies: A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Intra-operative Blood Loss</title>
          <description>The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis</description>
          <population>Intra-operative bleeding occurred in 29 of the 60 patients. For subjects with no intra-operative bleeding, volume was considered as 0 mL.</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="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patients with Intra-operative bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients age 3-5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients age 6-12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device</title>
        <description>Ability to dissect tonsils with investigational device via Likert Scale (Very Good, Good, Acceptable, Poor, Very Poor).</description>
        <time_frame>During Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>A Bipolar Instrument for Tonsillectomies</title>
            <description>A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.&#xD;
BiZact™: A bipolar instrument for tonsillectomies: A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device</title>
          <description>Ability to dissect tonsils with investigational device via Likert Scale (Very Good, Good, Acceptable, Poor, Very Poor).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)</title>
        <description>Ability to achieve hemostasis (arrest of bleeding, as assessed by visual inspection of the Investigator) without the use of other interventions (e.g. energy device or sutures)</description>
        <time_frame>During Procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>A Bipolar Instrument for Tonsillectomies</title>
            <description>A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.&#xD;
BiZact™: A bipolar instrument for tonsillectomies: A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)</title>
          <description>Ability to achieve hemostasis (arrest of bleeding, as assessed by visual inspection of the Investigator) without the use of other interventions (e.g. energy device or sutures)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>&quot;Number of Cases/Participants With Analgesic Consumption</title>
        <description>Analgesic consumption (standard of care) and concomitant medications (via patient diary).</description>
        <time_frame>28 days post-operatively</time_frame>
        <population>Caregivers were instructed to complete the take-home diary and record analgesics given on days 1-6, 7, 10, 14, and 28. Compliance with completing the diaries was not 100% and therefore we do not have data for all 60 subjects. Missing data was recorded as a protocol deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>A Bipolar Instrument for Tonsillectomies</title>
            <description>A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.&#xD;
BiZact™: A bipolar instrument for tonsillectomies: A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.</description>
          </group>
        </group_list>
        <measure>
          <title>&quot;Number of Cases/Participants With Analgesic Consumption</title>
          <description>Analgesic consumption (standard of care) and concomitant medications (via patient diary).</description>
          <population>Caregivers were instructed to complete the take-home diary and record analgesics given on days 1-6, 7, 10, 14, and 28. Compliance with completing the diaries was not 100% and therefore we do not have data for all 60 subjects. Missing data was recorded as a protocol deviation.</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="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Pain</title>
        <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
        <time_frame>Post-operative Day 4</time_frame>
        <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 4, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>BiZact Arm</title>
            <description>60 Pediatric subjects undergoing tonsillectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Pain</title>
          <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
          <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 4, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</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="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="2.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Pain</title>
        <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
        <time_frame>Post-operative Day 5</time_frame>
        <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 5, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>BiZact Arm</title>
            <description>60 Pediatric subjects undergoing tonsillectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Pain</title>
          <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
          <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 5, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</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="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="2.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Pain</title>
        <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
        <time_frame>Post-operative Day 6</time_frame>
        <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 57 caregivers completed the diary for day 6, so only 57 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>BiZact Arm</title>
            <description>60 Pediatric subjects undergoing tonsillectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Pain</title>
          <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
          <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 57 caregivers completed the diary for day 6, so only 57 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</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="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Pain</title>
        <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
        <time_frame>Post-operative Day 7</time_frame>
        <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 53 caregivers completed the diary for day 7, so only 53 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>BiZact Arm</title>
            <description>60 Pediatric subjects undergoing tonsillectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Pain</title>
          <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
          <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 53 caregivers completed the diary for day 7, so only 53 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</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="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Pain</title>
        <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
        <time_frame>Post-operative Day 10</time_frame>
        <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 57 caregivers completed the diary for day 10, so only 57 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>BiZact Arm</title>
            <description>60 Pediatric subjects undergoing tonsillectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Pain</title>
          <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
          <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 57 caregivers completed the diary for day 10, so only 57 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</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="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="2.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Pain</title>
        <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
        <time_frame>Post-operative Day 14</time_frame>
        <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 56 caregivers completed the diary for day 14, so only 56 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>BiZact Arm</title>
            <description>60 Pediatric subjects undergoing tonsillectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Pain</title>
          <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
          <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 56 caregivers completed the diary for day 14, so only 56 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</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="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Pain</title>
        <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
        <time_frame>Post-operative Day 28</time_frame>
        <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 57 caregivers completed the diary for day 28, so only 57 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>BiZact Arm</title>
            <description>60 Pediatric subjects undergoing tonsillectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Pain</title>
          <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
          <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 57 caregivers completed the diary for day 28, so only 57 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</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="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Pain</title>
        <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
        <time_frame>Day 1</time_frame>
        <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 1, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>BiZact Arm</title>
            <description>60 Pediatric subjects undergoing tonsillectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Pain</title>
          <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
          <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 1, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</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="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="2.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Pain</title>
        <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
        <time_frame>Day 2</time_frame>
        <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 2, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>BiZact Arm</title>
            <description>60 Pediatric subjects undergoing tonsillectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Pain</title>
          <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
          <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 2, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</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="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Pain</title>
        <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
        <time_frame>Day 3</time_frame>
        <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 3, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>BiZact Arm</title>
            <description>60 Pediatric subjects undergoing tonsillectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Pain</title>
          <description>Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 &quot;No Hurt&quot; to a crying face at 10 &quot;Hurts Worst&quot;.</description>
          <population>Post-operative pain levels were collected via patient diaries provided for the caregiver to complete. Only 58 caregivers completed the diary for day 3, so only 58 participants were included in the analysis. The missed days of data collection were recorded as protocol deviations.</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="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 0 (after commencement of surgery with BiZact™ to 28 (+7) days follow-up</time_frame>
      <desc>Definition of adverse event is consistent with clinicaltrials.gov.&#xD;
The relationship to the study-device was &quot;not related&quot; for 100% of Adverse Event (AE) reports. There have been no serious adverse events, unanticipated adverse device effects, unanticipated serious adverse device effects reported in the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>BiZact Arm</title>
          <description>60 Pediatric subjects undergoing tonsillectomy</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="60"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (22.0)</default_vocab>
        <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="27" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Bilateral Inferior Turbinate Hypertrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Ear Pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA (10.0)">Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Viral Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA (10.0)">Fever</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title vocab="MedDRA (10.0)">Influenza</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Cold</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Strep Throat</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Ear Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Swollen Tongue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Head Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Significant Pain in Throat</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA (10.0)">Right Knee Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="60"/>
              </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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Melody LaBeau, Director of Clinical Operations</name_or_title>
      <organization>Medtronic</organization>
      <phone>763.526.2931</phone>
      <email>melody.a.labeau@medtronic.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/NCT03266094
org study id: MDT17024BZP
nct id: NCT03266094
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to assess safety and performance with the use of the BiZact™
      device in tonsillectomy procedures in children and adolescents.
A prospective, multi-center, single arm, study of BiZact™ on children and adolescents
      undergoing tonsillectomy.

      Study Visits:

        -  Screening/Baseline

        -  Surgery, Day 0

        -  Post-Op Follow-up Day 1 - Day 7, Day 10, & Day 14 (Home assessments)

        -  Post-Op Follow-up Day 28 (Office Visit)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intra-operative Blood Loss
time frame: During procedure
description: The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis
measure: Number of Patients With Intra-operative Blood Loss
time frame: During procedure
description: The study will be considered a success if the mean intra-operative blood loss is less than the mean intra-operative blood loss associated with conventional tonsillectomy in a large meta-analysis
measure: Number of Cases/Participants Rated Under Different Categories Based on the Performance of the Investigational Device
time frame: During Procedure
description: Ability to dissect tonsils with investigational device via Likert Scale (Very Good, Good, Acceptable, Poor, Very Poor).
measure: Number of Cases With Ability to Achieve Hemostasis (Performance of the Investigational Device)
time frame: During Procedure
description: Ability to achieve hemostasis (arrest of bleeding, as assessed by visual inspection of the Investigator) without the use of other interventions (e.g. energy device or sutures)
measure: "Number of Cases/Participants With Analgesic Consumption
time frame: 28 days post-operatively
description: Analgesic consumption (standard of care) and concomitant medications (via patient diary).
measure: Post-operative Pain
time frame: Post-operative Day 4
description: Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
measure: Post-operative Pain
time frame: Post-operative Day 5
description: Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
measure: Post-operative Pain
time frame: Post-operative Day 6
description: Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
measure: Post-operative Pain
time frame: Post-operative Day 7
description: Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
measure: Post-operative Pain
time frame: Post-operative Day 10
description: Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
measure: Post-operative Pain
time frame: Post-operative Day 14
description: Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
measure: Post-operative Pain
time frame: Post-operative Day 28
description: Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
measure: Post-operative Pain
time frame: Day 1
description: Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
measure: Post-operative Pain
time frame: Day 2
description: Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
measure: Post-operative Pain
time frame: Day 3
description: Evaluation of post-operative pain incidence and severity measured using the Wong-Baker FACES® Pain Rating Scale, an illustrated pain scale ranging from a happy face at 0 "No Hurt" to a crying face at 10 "Hurts Worst".
arm group label: A bipolar instrument for tonsillectomies
arm group type: Other
description: A bipolar electrosurgical device that employs Radio frequency (RF) energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.
intervention type: Device
intervention name: BiZact™: A bipolar instrument for tonsillectomies
description: A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.
arm group label: A bipolar instrument for tonsillectomies
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
last name: Eugene Brown, MD
role: Principal Investigator
affiliation: Coastal Pediatric Research
facility: 
facility: 
country: United States
country: Australia
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 