<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/NCT02262039</url>
  </required_header>
  <id_info>
    <org_study_id>1405013985</org_study_id>
    <nct_id>NCT02262039</nct_id>
  </id_info>
  <brief_title>Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System</brief_title>
  <official_title>Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SurgiQuest, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the Airseal System will reduce post-operative&#xD;
      pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our hypothesis is that Airseal Insufflation System will provide reduced mean operative&#xD;
      insufflation pressure and operative mean ETCO2, resulting in improved post-operative pain&#xD;
      control and improved operative safety.&#xD;
&#xD;
      The Airseal System has demonstrated decreased variability in intra-abdominal pressure, less&#xD;
      post-operative shoulder pain, lower mean ETCO2 and reduced narcotic pain administration.&#xD;
      These metrics have been demonstrated in human subjects undergoing gynecologic, urologic and&#xD;
      bariatric procedures. The established benefits in a human model provide a foundation for&#xD;
      translating this technology to living kidney donors. The advantage lies in the ability to&#xD;
      improve pain-related outcomes in this population, which translates into increased living&#xD;
      donation; the single solution to reduce mortality for patients suffering from end-stage&#xD;
      kidney disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Narcotic Use (mg)</measure>
    <time_frame>Intra-Operative on day of surgery</time_frame>
    <description>Total Morphine Equivalents - mean in mg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Narcotic Use (mg)</measure>
    <time_frame>Post-operative (until time of discharge, typically 2-4 days)</time_frame>
    <description>Total Morphine Equivalents - mean in mg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Narcotic Use (mg)</measure>
    <time_frame>Operative and Post-operative (until time of discharge, typically 2-4 days)</time_frame>
    <description>Total Morphine Equivalent - mean in mg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Pain Score</measure>
    <time_frame>1 hour post-op</time_frame>
    <description>Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Pain Score</measure>
    <time_frame>6 hours post-op</time_frame>
    <description>Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Pain Score</measure>
    <time_frame>12 hours post-op</time_frame>
    <description>Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean ETCO2</measure>
    <time_frame>intraoperative</time_frame>
    <description>mean End-tidal carbon dioxide concentration in the expired air</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Conventional Pressure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional Insufflation with 15mmHg target pressure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Pressure (VTI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Valveless recirculating insufflation (VTI) with 10mmHg target pressure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Valveless recirculating insufflation (VTI)</intervention_name>
    <description>10 mmHg target pressure</description>
    <arm_group_label>Low Pressure (VTI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional pressure</intervention_name>
    <description>15 mmHg target pressure</description>
    <arm_group_label>Conventional Pressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any living donor who has been approved to donate a kidney is eligible to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sanjay Kulkarni, MD</last_name>
    <role>Study Director</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale New Haven Transplantation Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <results_first_submitted>September 8, 2016</results_first_submitted>
  <results_first_submitted_qc>October 31, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 23, 2016</results_first_posted>
  <last_update_submitted>January 12, 2018</last_update_submitted>
  <last_update_submitted_qc>January 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>living</keyword>
  <keyword>kidney</keyword>
  <keyword>donors</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Conventional Pressure</title>
          <description>15mmHg target pressure</description>
        </group>
        <group group_id="P2">
          <title>Low Pressure (VTI)</title>
          <description>10mmHg target pressure&#xD;
VTI = Valveless recirculating insufflation</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who agreed to participate completed the study and are included in the analysis.</population>
      <group_list>
        <group group_id="B1">
          <title>Conventional Pressure</title>
          <description>15mmHg target pressure</description>
        </group>
        <group group_id="B2">
          <title>Low Pressure (VTI)</title>
          <description>10mmHg target pressure&#xD;
VTI= Valveless recirculating insufflation</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="41"/>
          </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="45.6" spread="12.3"/>
                    <measurement group_id="B2" value="51.6" spread="14.5"/>
                    <measurement group_id="B3" value="47.6" spread="13.2"/>
                  </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="8"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nephrectomy Laterality</title>
          <description>This refers to the location (left side vs. right side) of the kidney removed during the donor surgery</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ASA Class</title>
          <description>American Society of Anesthesiologists: ASA physical status classification system to assess fitness of patients before surgery.&#xD;
Classifications range from 1 (Healthy Person) to 6 (Declared brain-dead)&#xD;
Only participants in groups 1 and 2 (Healthy or mild systemic disease) are eligible to become living kidney donors.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Narcotic Use (mg)</title>
        <description>Total Morphine Equivalents - mean in mg</description>
        <time_frame>Intra-Operative on day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Pressure</title>
            <description>15mmHg target pressure</description>
          </group>
          <group group_id="O2">
            <title>Low Pressure (VTI)</title>
            <description>10mmHg target pressure&#xD;
VTI= Valveless recirculating insufflation</description>
          </group>
        </group_list>
        <measure>
          <title>Narcotic Use (mg)</title>
          <description>Total Morphine Equivalents - mean in mg</description>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.8" spread="19"/>
                    <measurement group_id="O2" value="99.6" spread="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Narcotic Use (mg)</title>
        <description>Total Morphine Equivalents - mean in mg</description>
        <time_frame>Post-operative (until time of discharge, typically 2-4 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Pressure</title>
            <description>15mmHg target pressure</description>
          </group>
          <group group_id="O2">
            <title>Low Pressure (VTI)</title>
            <description>10mmHg target pressure&#xD;
VTI= Valveless recirculating insufflation</description>
          </group>
        </group_list>
        <measure>
          <title>Narcotic Use (mg)</title>
          <description>Total Morphine Equivalents - mean in mg</description>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130.8" spread="125.6"/>
                    <measurement group_id="O2" value="134.5" spread="80.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.92</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Narcotic Use (mg)</title>
        <description>Total Morphine Equivalent - mean in mg</description>
        <time_frame>Operative and Post-operative (until time of discharge, typically 2-4 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Pressure</title>
            <description>15mmHg target pressure</description>
          </group>
          <group group_id="O2">
            <title>Low Pressure (VTI)</title>
            <description>10mmHg target pressure&#xD;
VTI= Valveless recirculating insufflation</description>
          </group>
        </group_list>
        <measure>
          <title>Narcotic Use (mg)</title>
          <description>Total Morphine Equivalent - mean in mg</description>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="244.6" spread="126.7"/>
                    <measurement group_id="O2" value="234.0" spread="88.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.78</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Pain Score</title>
        <description>Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.</description>
        <time_frame>1 hour post-op</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Pressure</title>
            <description>15mmHg target pressure</description>
          </group>
          <group group_id="O2">
            <title>Low Pressure (VTI)</title>
            <description>10mmHg target pressure&#xD;
VTI= Valveless recirculating insufflation</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Pain Score</title>
          <description>Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.</description>
          <units>units 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="14"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="3.2"/>
                    <measurement group_id="O2" value="5.3" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.52</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Pain Score</title>
        <description>Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain.</description>
        <time_frame>6 hours post-op</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Pressure</title>
            <description>15mmHg target pressure</description>
          </group>
          <group group_id="O2">
            <title>Low Pressure (VTI)</title>
            <description>10mmHg target pressure&#xD;
VTI= Valveless recirculating insufflation</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Pain Score</title>
          <description>Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain.</description>
          <units>units 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="14"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="3.2"/>
                    <measurement group_id="O2" value="4.6" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.25</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Pain Score</title>
        <description>Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.</description>
        <time_frame>12 hours post-op</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Pressure</title>
            <description>15mmHg target pressure</description>
          </group>
          <group group_id="O2">
            <title>Low Pressure (VTI)</title>
            <description>10mmHg target pressure&#xD;
VTI= Valveless recirculating insufflation</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Pain Score</title>
          <description>Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.</description>
          <units>units 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="14"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="3.0"/>
                    <measurement group_id="O2" value="3.7" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.82</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean ETCO2</title>
        <description>mean End-tidal carbon dioxide concentration in the expired air</description>
        <time_frame>intraoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Pressure</title>
            <description>15mmHg target pressure</description>
          </group>
          <group group_id="O2">
            <title>Low Pressure (VTI)</title>
            <description>10mmHg target pressure&#xD;
VTI= Valveless recirculating insufflation</description>
          </group>
        </group_list>
        <measure>
          <title>Mean ETCO2</title>
          <description>mean End-tidal carbon dioxide concentration in the expired air</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.7" spread="4.4"/>
                    <measurement group_id="O2" value="30.8" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.45</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month</time_frame>
      <desc>Systematic chart reviews were conducted</desc>
      <group_list>
        <group group_id="E1">
          <title>Conventional Pressure</title>
          <description>15mmHg target pressure</description>
        </group>
        <group group_id="E2">
          <title>Low Pressure (VTI)</title>
          <description>10mmHg target pressure&#xD;
VTI= Valveless recirculating insufflation</description>
        </group>
      </group_list>
      <serious_events>
        <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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="3" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aspiration pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Post-operative hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="27"/>
              </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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Sanjay Kulkarni</name_or_title>
      <organization>Yale University</organization>
      <phone>203-785-6501</phone>
      <email>sanjay.kulkarni@yale.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02262039
org study id: 1405013985
nct id: NCT02262039
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine if the Airseal System will reduce post-operative
      pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.
Our hypothesis is that Airseal Insufflation System will provide reduced mean operative
      insufflation pressure and operative mean ETCO2, resulting in improved post-operative pain
      control and improved operative safety.

      The Airseal System has demonstrated decreased variability in intra-abdominal pressure, less
      post-operative shoulder pain, lower mean ETCO2 and reduced narcotic pain administration.
      These metrics have been demonstrated in human subjects undergoing gynecologic, urologic and
      bariatric procedures. The established benefits in a human model provide a foundation for
      translating this technology to living kidney donors. The advantage lies in the ability to
      improve pain-related outcomes in this population, which translates into increased living
      donation; the single solution to reduce mortality for patients suffering from end-stage
      kidney disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Narcotic Use (mg)
time frame: Intra-Operative on day of surgery
description: Total Morphine Equivalents - mean in mg
measure: Narcotic Use (mg)
time frame: Post-operative (until time of discharge, typically 2-4 days)
description: Total Morphine Equivalents - mean in mg
measure: Narcotic Use (mg)
time frame: Operative and Post-operative (until time of discharge, typically 2-4 days)
description: Total Morphine Equivalent - mean in mg
measure: Subjective Pain Score
time frame: 1 hour post-op
description: Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.
measure: Subjective Pain Score
time frame: 6 hours post-op
description: Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain.
measure: Subjective Pain Score
time frame: 12 hours post-op
description: Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.
measure: Mean ETCO2
time frame: intraoperative
description: mean End-tidal carbon dioxide concentration in the expired air
arm group label: Conventional Pressure
arm group type: Active Comparator
description: Conventional Insufflation with 15mmHg target pressure
arm group label: Low Pressure (VTI)
arm group type: Experimental
description: Valveless recirculating insufflation (VTI) with 10mmHg target pressure
intervention type: Device
intervention name: Valveless recirculating insufflation (VTI)
description: 10 mmHg target pressure
arm group label: Low Pressure (VTI)
intervention type: Device
intervention name: Conventional pressure
description: 15 mmHg target pressure
arm group label: Conventional Pressure
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sanjay Kulkarni, MD
role: Study Director
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 