<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/NCT02196675</url>
  </required_header>
  <id_info>
    <org_study_id>ESC-13-003</org_study_id>
    <nct_id>NCT02196675</nct_id>
  </id_info>
  <brief_title>Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea</brief_title>
  <official_title>A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea</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>
      Collection of real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung&#xD;
      cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm&#xD;
      and/or 60 mm (study devices) in a Korean population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial assessed the use of a powered stapler for transection in VATS lung&#xD;
      resection, where there is currently limited published clinical data. The primary study&#xD;
      endpoint was occurrence and duration of air leak / prolonged air leak (PAL). Procedure&#xD;
      details and perioperative outcomes associated with VATS lung resections were also evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of Prolonged Air Leaks</measure>
    <time_frame>Post-operative period through hospital discharge and follow-up at Day 30</time_frame>
    <description>Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Postoperative Air Leaks</measure>
    <time_frame>Post-operative period through hospital discharge and follow-up at Day 30</time_frame>
    <description>Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay (LOS)</measure>
    <time_frame>Post-operative period through hospital discharge and follow-up at Day 30</time_frame>
    <description>Determined as the length of time in days from hospital admission to initial hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Estimated Intra-operative Blood Loss</measure>
    <time_frame>Blood loss intra-op and up to 5 days post-op</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Chest Tube Removal</measure>
    <time_frame>Post-operative period through hospital discharge and follow-up at Day 30</time_frame>
    <description>Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">105</enrollment>
  <condition>Non-small Cell Lung Cancer (NSCLC)</condition>
  <arm_group>
    <arm_group_label>VATS wedge resection or lobectomy</arm_group_label>
    <description>Single arm study Intervention: Device: Endocutter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endocutter</intervention_name>
    <description>The study utilized Echelon FlexTM Powered ENDOPATH® Stapler (Ethicon, Cincinnati, USA) along with compatible cartridges: Gray (closed staple height, 0.75mm), White (1.0mm), Blue (1.5mm), Gold (1.8mm), Green (2.0mm), and Black (2.3mm).</description>
    <arm_group_label>VATS wedge resection or lobectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals with suspected or confirmed of NSCLC (up to and including Stage II), or&#xD;
        individuals undergoing VATS diagnostic wedge resection in accordance with their&#xD;
        institution's Standard of care (SOC);&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected or confirmed of NSCLC (up to and including Stage II), or individuals&#xD;
             undergoing VATS diagnostic wedge resection in accordance with their institution's&#xD;
             Standard of care (SOC);&#xD;
&#xD;
          -  Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one&#xD;
             lobe of the lung;&#xD;
&#xD;
          -  Performance status 0-1 (Eastern Cooperative Oncology Group classification);&#xD;
&#xD;
          -  ASA score ≤ 3;&#xD;
&#xD;
          -  No prior history of VATS or open lung surgery;&#xD;
&#xD;
          -  Willing to give consent and comply with study-related evaluation and treatment&#xD;
             schedule; and&#xD;
&#xD;
          -  At least 19 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active (subject currently receiving systemic treatment) bacterial infection or fungal&#xD;
             infection;&#xD;
&#xD;
          -  Systemic administration (intravenous or oral) of steroids, including herbal&#xD;
             supplements that contain steroids, (within 30 days prior to study procedure);&#xD;
&#xD;
          -  Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days&#xD;
             prior to the procedure;&#xD;
&#xD;
          -  Scheduled concurrent surgical procedure other than wedge resection or lobectomy&#xD;
             (central venous access - e.g., port placement, mediastinoscopy with lymph node&#xD;
             sampling, and VATS lymphadenectomy are allowed);&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Physical or psychological condition which would impair study participation;&#xD;
&#xD;
          -  The patient is judged unsuitable for study participation by the Investigator for any&#xD;
             other reason; or&#xD;
&#xD;
          -  Unable or unwilling to attend follow-up visits and examinations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elliott Fegelman, MD</last_name>
    <role>Study Director</role>
    <affiliation>Johnson &amp; Johson</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>410-769</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korean University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>152-703</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <results_first_submitted>November 16, 2015</results_first_submitted>
  <results_first_submitted_qc>November 16, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 18, 2015</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 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Individuals undergoing VATS lobectomy for suspected or confirmed Non-small Cell Lung Cancer, or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of Care, and who meet study entry criteria, were enrolled in this study.</recruitment_details>
      <pre_assignment_details>There was no assignment to treatment group given that this is a single arm study wherein the same device was used on all subjects. Results are presented for the overall cohort as well as by the individual procedure performed - lobectomy, wedge resection, or wedge resection with lobectomy.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Wedge Resection</title>
          <description>Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler</description>
        </group>
        <group group_id="P2">
          <title>Lobectomy</title>
          <description>Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler</description>
        </group>
        <group group_id="P3">
          <title>Wedge Resection With Lobectomy</title>
          <description>Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="70"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="68"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Intra-operative surgical exclusion</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure. Two enrolled subjects were converted to an open procedure and thus were not included in this summary. These subjects were followed for safety.</population>
      <group_list>
        <group group_id="B1">
          <title>Wedge Resection</title>
          <description>Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler</description>
        </group>
        <group group_id="B2">
          <title>Lobectomy</title>
          <description>Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler</description>
        </group>
        <group group_id="B3">
          <title>Wedge Resection With Lobectomy</title>
          <description>Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
            <count group_id="B2" value="69"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="103"/>
          </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="62.8" spread="11.39"/>
                    <measurement group_id="B2" value="60.5" spread="10.41"/>
                    <measurement group_id="B3" value="61.6" spread="8.09"/>
                    <measurement group_id="B4" value="61.2" spread="10.47"/>
                  </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="13"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" 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>Korea, Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Occurrence of Prolonged Air Leaks</title>
        <description>Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).</description>
        <time_frame>Post-operative period through hospital discharge and follow-up at Day 30</time_frame>
        <population>All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure</population>
        <group_list>
          <group group_id="O1">
            <title>Wedge Resection</title>
            <description>Subjects undergoing VATS wedge resection</description>
          </group>
          <group group_id="O2">
            <title>Lobectomy</title>
            <description>Subjects undergoing VATS lobectomy</description>
          </group>
          <group group_id="O3">
            <title>Wedge Resection With Lobectomy</title>
            <description>Subjects undergoing VATS wedge resection that also required lobectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Occurrence of Prolonged Air Leaks</title>
          <description>Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).</description>
          <population>All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure</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="26"/>
                <count group_id="O2" value="69"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="13.2"/>
                    <measurement group_id="O2" value="5.8" lower_limit="1.6" upper_limit="14.2"/>
                    <measurement group_id="O3" value="37.5" lower_limit="8.5" upper_limit="75.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurrence of Postoperative Air Leaks</title>
        <description>Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).</description>
        <time_frame>Post-operative period through hospital discharge and follow-up at Day 30</time_frame>
        <population>ll subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure</population>
        <group_list>
          <group group_id="O1">
            <title>Wedge Resection</title>
            <description>Subjects undergoing VATS wedge resection</description>
          </group>
          <group group_id="O2">
            <title>Lobectomy</title>
            <description>Subjects undergoing VATS lobectomy</description>
          </group>
          <group group_id="O3">
            <title>Wedge Resection With Lobectomy</title>
            <description>Subjects undergoing VATS wedge resection that also required lobectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Occurrence of Postoperative Air Leaks</title>
          <description>Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).</description>
          <population>ll subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure</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="26"/>
                <count group_id="O2" value="69"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8" lower_limit="14.3" upper_limit="51.8"/>
                    <measurement group_id="O2" value="42.0" lower_limit="30.2" upper_limit="54.5"/>
                    <measurement group_id="O3" value="75.0" lower_limit="34.9" upper_limit="96.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Stay (LOS)</title>
        <description>Determined as the length of time in days from hospital admission to initial hospital discharge</description>
        <time_frame>Post-operative period through hospital discharge and follow-up at Day 30</time_frame>
        <population>All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure and had complete data. One subject was missing the hospital discharge date, thus length of stay could not be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Wedge Resection</title>
            <description>Subjects undergoing VATS wedge resection</description>
          </group>
          <group group_id="O2">
            <title>Lobectomy</title>
            <description>Subjects undergoing VATS lobectomy</description>
          </group>
          <group group_id="O3">
            <title>Wedge Resection With Lobectomy</title>
            <description>Subjects undergoing VATS wedge resection that also required lobectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay (LOS)</title>
          <description>Determined as the length of time in days from hospital admission to initial hospital discharge</description>
          <population>All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure and had complete data. One subject was missing the hospital discharge date, thus length of stay could not be calculated.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="69"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" spread="2.95"/>
                    <measurement group_id="O2" value="9.3" spread="4.07"/>
                    <measurement group_id="O3" value="9.4" spread="2.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume of Estimated Intra-operative Blood Loss</title>
        <time_frame>Blood loss intra-op and up to 5 days post-op</time_frame>
        <population>All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure</population>
        <group_list>
          <group group_id="O1">
            <title>Wedge Resection</title>
            <description>Subjects undergoing VATS wedge resection</description>
          </group>
          <group group_id="O2">
            <title>Lobectomy</title>
            <description>Subjects undergoing VATS lobectomy</description>
          </group>
          <group group_id="O3">
            <title>Wedge Resection With Lobectomy</title>
            <description>Subjects undergoing VATS wedge resection that also required lobectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Estimated Intra-operative Blood Loss</title>
          <population>All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure</population>
          <units>milliliters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="69"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.4" spread="40.27"/>
                    <measurement group_id="O2" value="146.1" spread="155.96"/>
                    <measurement group_id="O3" value="91.3" spread="124.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Chest Tube Removal</title>
        <description>Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.</description>
        <time_frame>Post-operative period through hospital discharge and follow-up at Day 30</time_frame>
        <population>All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure</population>
        <group_list>
          <group group_id="O1">
            <title>Wedge Resection</title>
            <description>Subjects undergoing VATS wedge resection</description>
          </group>
          <group group_id="O2">
            <title>Lobectomy</title>
            <description>Subjects undergoing VATS lobectomy</description>
          </group>
          <group group_id="O3">
            <title>Wedge Resection With Lobectomy</title>
            <description>Subjects undergoing VATS wedge resection that also required lobectomy</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Chest Tube Removal</title>
          <description>Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.</description>
          <population>All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="69"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="1.63"/>
                    <measurement group_id="O2" value="5.2" spread="1.97"/>
                    <measurement group_id="O3" value="6.3" spread="2.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Duration of follow-up was scheduled through approximately 4 weeks post surgery</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Wedge Resection</title>
          <description>Subjects undergoing VATS wedge resection</description>
        </group>
        <group group_id="E2">
          <title>Lobectomy</title>
          <description>Subjects undergoing VATS lobectomy</description>
        </group>
        <group group_id="E3">
          <title>Wedge Resection With Lobectomy</title>
          <description>Subjects undergoing VATS wedge resection that also required lobectomy</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (12.0)</default_vocab>
        <default_assessment>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="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Postoperative ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Vocal cord paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pulmonary air leakage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (12.0)</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="17" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="70"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
              </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>Prior to submission for publication or presentation, the Institution will provide Sponsor with at least sixty (60) days for review of a manuscript. Notwithstanding the foregoing, no paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written consent.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael Schwiers, Principal Biostatistician</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/NCT02196675
org study id: ESC-13-003
nct id: NCT02196675
lead sponsor: 
has dmc: No
Collection of real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung
      cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm
      and/or 60 mm (study devices) in a Korean population.
This clinical trial assessed the use of a powered stapler for transection in VATS lung
      resection, where there is currently limited published clinical data. The primary study
      endpoint was occurrence and duration of air leak / prolonged air leak (PAL). Procedure
      details and perioperative outcomes associated with VATS lung resections were also evaluated.
observational model: Cohort
time perspective: Prospective
measure: Occurrence of Prolonged Air Leaks
time frame: Post-operative period through hospital discharge and follow-up at Day 30
description: Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).
measure: Occurrence of Postoperative Air Leaks
time frame: Post-operative period through hospital discharge and follow-up at Day 30
description: Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).
measure: Length of Stay (LOS)
time frame: Post-operative period through hospital discharge and follow-up at Day 30
description: Determined as the length of time in days from hospital admission to initial hospital discharge
measure: Volume of Estimated Intra-operative Blood Loss
time frame: Blood loss intra-op and up to 5 days post-op
measure: Time to Chest Tube Removal
time frame: Post-operative period through hospital discharge and follow-up at Day 30
description: Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.
arm group label: VATS wedge resection or lobectomy
description: Single arm study Intervention: Device: Endocutter
intervention type: Device
intervention name: Endocutter
description: The study utilized Echelon FlexTM Powered ENDOPATH® Stapler (Ethicon, Cincinnati, USA) along with compatible cartridges: Gray (closed staple height, 0.75mm), White (1.0mm), Blue (1.5mm), Gold (1.8mm), Green (2.0mm), and Black (2.3mm).
arm group label: VATS wedge resection or lobectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Elliott Fegelman, MD
role: Study Director
affiliation: Johnson & Johson
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 