<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/NCT02248246</url>
  </required_header>
  <id_info>
    <org_study_id>ENG-14-001</org_study_id>
    <nct_id>NCT02248246</nct_id>
  </id_info>
  <brief_title>Harmonic ACE®+7 Shears in Laparoscopic Colectomy</brief_title>
  <official_title>Prospective, Multicenter, Observational Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Laparoscopic Colectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ethicon Endo-Surgery</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ethicon Endo-Surgery</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, non-randomized, single arm, multicenter, observational study to assess&#xD;
      the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing&#xD;
      during laparoscopic colectomy. The study will not modify or influence current surgeon&#xD;
      technique. Investigators will perform each procedure using the device in compliance with&#xD;
      their standard surgical approach and product labeling.&#xD;
&#xD;
      The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in&#xD;
      accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled,&#xD;
      calibrated, and/or used in accordance with manufacturer design specifications, product&#xD;
      instructions and guidelines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Population: Subjects enrolled into this study will undergo elective laparoscopic&#xD;
      colectomy wherein dissection and transection of the (inferior mesenteric artery) IMA is&#xD;
      indicated.&#xD;
&#xD;
      Primary Variable: Incidence of hemostasis at the IMA Secondary Endpoint: Incidence of&#xD;
      hemostasis at the inferior mesenteric vain (IMV).&#xD;
&#xD;
      Definition: Hemostasis of the IMA and IMV is a dichotomous variable (i.e. yes or no). &quot;Yes&quot;&#xD;
      is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the&#xD;
      IMA and IMV.&#xD;
&#xD;
      Additional exploratory endpoints include:&#xD;
&#xD;
      The percentage of subjects requiring additional measures to obtain hemostasis on the IMA&#xD;
      and/or IMV, if identified:&#xD;
&#xD;
        -  Number of Harmonic touch ups - frequency of Harmonic reapplications required due to&#xD;
           oozing or bleeding at initial transection of named vessels&#xD;
&#xD;
        -  Use of other energy devices (tissue sealers, cautery devices) - Graded as yes or no; if&#xD;
           &quot;yes&quot;, the type, transection time (using stopwatch), time of application (24 hour clock)&#xD;
&#xD;
        -  Use of hemostatic products (e.g. hemoclips, staples, sutures, fibrin sealants) - Graded&#xD;
           as yes or no; if &quot;yes&quot;, the type and name of product, number/volume, and time of&#xD;
           application (24 hour clock)&#xD;
&#xD;
      Summary of the use of additional treatment after first pass hemostasis has already been&#xD;
      achieved at the IMA and IMV. Graded as yes or no; if &quot;yes&quot;, the type, number/volume, time of&#xD;
      application (24 hour clock) and rationale for use.&#xD;
&#xD;
      Adverse events attributed to the study device or procedure will be collected from time of&#xD;
      surgery to Visit 4 (Approximately 4 weeks after study surgery or as per standard of care&#xD;
      (SOC)).&#xD;
&#xD;
      Sample size: No formal sample size determination is required for this study. Approximately 40&#xD;
      subjects from the United States and the European Union are planned to be enrolled into this&#xD;
      study.&#xD;
&#xD;
      Global indication for use of the The Harmonic ACE®+7, 5mm Diameter Shears with Advanced&#xD;
      Hemostasis:&#xD;
&#xD;
      Indicated for soft tissue incisions when bleeding control and minimal thermal injury are&#xD;
      desired. The instruments can be used as an adjunct to or substitute for electrosurgery,&#xD;
      lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic,&#xD;
      exposure to orthopedic structures (such as spine and joint space), sealing and transection of&#xD;
      lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the&#xD;
      coagulation of vessels up to and including 7mm in diameter, using the Advanced Hemostasis&#xD;
      function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 4</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>Percentage of Participants With Hemostasis at the IMA</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>Hemostasis of the IMA is a dichotomous variable (i.e. yes or no). &quot;Yes&quot; is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Hemostasis at the IMV</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>Hemostasis of the IMV is a dichotomous variable (i.e. yes or no). &quot;Yes&quot; is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMV.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Benign or Malignant Disease Indicated for Colectomy</condition>
  <arm_group>
    <arm_group_label>Colectomy with Harmonic ACE®+7 Shears</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Harmonic ACE®+7 Shears</intervention_name>
    <description>Vessel sealing performance assessed for transection and sealing of the following named vessels:&#xD;
Inferior mesenteric artery (IMA)&#xD;
Inferior mesenteric vein (IMV) (if identified)</description>
    <arm_group_label>Colectomy with Harmonic ACE®+7 Shears</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Indicated for elective laparoscopic colectomy&#xD;
&#xD;
          2. Planned dissection and transection of the IMA&#xD;
&#xD;
          3. Age: equal to or more than18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Preoperative exclusion criteria:&#xD;
&#xD;
          1. Known or suspected uncontrolled bleeding disorders&#xD;
&#xD;
          2. Subjects unlikely to comply with protocol procedures or adhere to the study visit&#xD;
             schedule&#xD;
&#xD;
          3. Any condition rendering a subject unable to understand the nature, scope, and possible&#xD;
             consequences of the study or study procedures, or&#xD;
&#xD;
          4. Any Subject unwilling to sign the study informed consent document&#xD;
&#xD;
             Intra-operative exclusion criteria:&#xD;
&#xD;
          5. Prior to transection of the IMA, the investigator prospectively concludes the&#xD;
             inability to safely isolate and transect the IMA with exclusive use of study device&#xD;
             while adhering to the instructions for use, or&#xD;
&#xD;
          6. Any intra-operative findings identified by the surgeon that may preclude conduct of&#xD;
             the study procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jackson Medical Group</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorectal Surgical Associates Ltd, LLP</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg, Dept of Surgical Oncology</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Surrey County Hospital NHS Trust</name>
      <address>
        <city>Guildford</city>
        <state>Surrey</state>
        <zip>GU2 7XX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Plasencia G, Van der Speeten K, Hinoul P, Kelch JA, Batiller J, Severin KS, Schwiers ML, Rockall T. Large-Vessel Sealing in Laparoscopic Colectomy with an Ultrasonic Device. JSLS. 2016 Apr-Jun;20(2):e2016.00010. doi: 10.4293/JSLS.2016.00010.</citation>
    <PMID>27186065</PMID>
  </reference>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>March 2, 2016</results_first_submitted>
  <results_first_submitted_qc>March 2, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 1, 2016</results_first_posted>
  <last_update_submitted>June 16, 2016</last_update_submitted>
  <last_update_submitted_qc>June 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hemostasis</keyword>
  <keyword>Harmonic ACE®+7 Shears</keyword>
  <keyword>Laparoscopic</keyword>
  <keyword>Inferior mesenteric artery</keyword>
  <keyword>Inferior mesenteric vein</keyword>
  <keyword>Observational</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Colectomy With Harmonic ACE®+7 Shears</title>
          <description>Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection&#xD;
Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:&#xD;
Inferior mesenteric artery (IMA)&#xD;
Inferior mesenteric vein (IMV) (if identified)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Set - all subjects in whom the procedure was started.</population>
      <group_list>
        <group group_id="B1">
          <title>Colectomy With Harmonic ACE®+7 Shears</title>
          <description>Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection&#xD;
Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:&#xD;
Inferior mesenteric artery (IMA)&#xD;
Inferior mesenteric vein (IMV) (if identified)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
          </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="59.8" spread="13.3"/>
                  </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="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </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>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Hemostasis at the IMA</title>
        <description>Hemostasis of the IMA is a dichotomous variable (i.e. yes or no). &quot;Yes&quot; is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMA.</description>
        <time_frame>Intraoperatively</time_frame>
        <population>Safety Set - all subjects in whom the procedure was started.</population>
        <group_list>
          <group group_id="O1">
            <title>Colectomy With Harmonic ACE®+7 Shears</title>
            <description>Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection&#xD;
Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:&#xD;
Inferior mesenteric artery (IMA)&#xD;
Inferior mesenteric vein (IMV) (if identified)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Hemostasis at the IMA</title>
          <description>Hemostasis of the IMA is a dichotomous variable (i.e. yes or no). &quot;Yes&quot; is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMA.</description>
          <population>Safety Set - all subjects in whom the procedure was started.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="91.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Hemostasis at the IMV</title>
        <description>Hemostasis of the IMV is a dichotomous variable (i.e. yes or no). &quot;Yes&quot; is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMV.</description>
        <time_frame>Intraoperatively</time_frame>
        <population>Safety Set - all subjects in whom the procedure was started.</population>
        <group_list>
          <group group_id="O1">
            <title>Colectomy With Harmonic ACE®+7 Shears</title>
            <description>Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection&#xD;
Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:&#xD;
Inferior mesenteric artery (IMA)&#xD;
Inferior mesenteric vein (IMV) (if identified)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Hemostasis at the IMV</title>
          <description>Hemostasis of the IMV is a dichotomous variable (i.e. yes or no). &quot;Yes&quot; is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMV.</description>
          <population>Safety Set - all subjects in whom the procedure was started.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.5" lower_limit="86.8" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Colectomy With Harmonic ACE®+7 Shears</title>
          <description>Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection&#xD;
Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:&#xD;
Inferior mesenteric artery (IMA)&#xD;
Inferior mesenteric vein (IMV) (if identified)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v 16.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA v 16">Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA v 16">Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal anastomotic leak</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Postoperative ileus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Procedural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Splenic haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v 16.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="40"/>
              </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 PIs agreed that the first publication of results should be made in conjunction with the presentation of a joint, multicenter publication of the results with all PIs contributing data, analyses, and comments. If this publication was not submitted within 12 months after conclusion of the Study at all sites, or after Sponsor confirmed there would be no multicenter Study publication, whichever is first, the PIs could have published the results from their individual sites.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael Schwiers</name_or_title>
      <organization>Ethicon</organization>
      <phone>513-337-1172</phone>
      <email>mschwier@its.jnj.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/NCT02248246
org study id: ENG-14-001
nct id: NCT02248246
lead sponsor: 
has dmc: No
This is a prospective, non-randomized, single arm, multicenter, observational study to assess
      the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing
      during laparoscopic colectomy. The study will not modify or influence current surgeon
      technique. Investigators will perform each procedure using the device in compliance with
      their standard surgical approach and product labeling.

      The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in
      accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled,
      calibrated, and/or used in accordance with manufacturer design specifications, product
      instructions and guidelines.
Study Population: Subjects enrolled into this study will undergo elective laparoscopic
      colectomy wherein dissection and transection of the (inferior mesenteric artery) IMA is
      indicated.

      Primary Variable: Incidence of hemostasis at the IMA Secondary Endpoint: Incidence of
      hemostasis at the inferior mesenteric vain (IMV).

      Definition: Hemostasis of the IMA and IMV is a dichotomous variable (i.e. yes or no). "Yes"
      is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the
      IMA and IMV.

      Additional exploratory endpoints include:

      The percentage of subjects requiring additional measures to obtain hemostasis on the IMA
      and/or IMV, if identified:

        -  Number of Harmonic touch ups - frequency of Harmonic reapplications required due to
           oozing or bleeding at initial transection of named vessels

        -  Use of other energy devices (tissue sealers, cautery devices) - Graded as yes or no; if
           "yes", the type, transection time (using stopwatch), time of application (24 hour clock)

        -  Use of hemostatic products (e.g. hemoclips, staples, sutures, fibrin sealants) - Graded
           as yes or no; if "yes", the type and name of product, number/volume, and time of
           application (24 hour clock)

      Summary of the use of additional treatment after first pass hemostasis has already been
      achieved at the IMA and IMV. Graded as yes or no; if "yes", the type, number/volume, time of
      application (24 hour clock) and rationale for use.

      Adverse events attributed to the study device or procedure will be collected from time of
      surgery to Visit 4 (Approximately 4 weeks after study surgery or as per standard of care
      (SOC)).

      Sample size: No formal sample size determination is required for this study. Approximately 40
      subjects from the United States and the European Union are planned to be enrolled into this
      study.

      Global indication for use of the The Harmonic ACE®+7, 5mm Diameter Shears with Advanced
      Hemostasis:

      Indicated for soft tissue incisions when bleeding control and minimal thermal injury are
      desired. The instruments can be used as an adjunct to or substitute for electrosurgery,
      lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic,
      exposure to orthopedic structures (such as spine and joint space), sealing and transection of
      lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the
      coagulation of vessels up to and including 7mm in diameter, using the Advanced Hemostasis
      function.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Hemostasis at the IMA
time frame: Intraoperatively
description: Hemostasis of the IMA is a dichotomous variable (i.e. yes or no). "Yes" is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMA.
measure: Percentage of Participants With Hemostasis at the IMV
time frame: Intraoperatively
description: Hemostasis of the IMV is a dichotomous variable (i.e. yes or no). "Yes" is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMV.
arm group label: Colectomy with Harmonic ACE®+7 Shears
arm group type: Other
description: Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection
intervention type: Device
intervention name: Harmonic ACE®+7 Shears
description: Vessel sealing performance assessed for transection and sealing of the following named vessels:
Inferior mesenteric artery (IMA)
Inferior mesenteric vein (IMV) (if identified)
arm group label: Colectomy with Harmonic ACE®+7 Shears
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: United Kingdom
country: United States
citation: Plasencia G, Van der Speeten K, Hinoul P, Kelch JA, Batiller J, Severin KS, Schwiers ML, Rockall T. Large-Vessel Sealing in Laparoscopic Colectomy with an Ultrasonic Device. JSLS. 2016 Apr-Jun;20(2):e2016.00010. doi: 10.4293/JSLS.2016.00010.
PMID: 27186065
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 