<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/NCT03043079</url>
  </required_header>
  <id_info>
    <org_study_id>823896</org_study_id>
    <nct_id>NCT03043079</nct_id>
  </id_info>
  <brief_title>Ultrasound Assessment of Ventral Hernia Defects</brief_title>
  <official_title>Ultrasound Assessment of Ventral Hernia Defects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Quantitative radiographic imaging holds promise as a novel and innovative strategy to assess&#xD;
      ventral hernia patients. Assessing abdominal wall changes surrounding ventral hernia using&#xD;
      shear wave velocity values measured with ultrasound will identify features of the abdominal&#xD;
      wall that differ between healthy volunteers and subjects scheduled to have ventral hernia&#xD;
      repair. Through the use of ultrasound including shear wave velocity measurements, the&#xD;
      abdominal wall of 25 subjects scheduled to have ventral hernia repair will be compared to&#xD;
      those of 35 healthy volunteers. The ultrasound measurements will elucidate if ventral hernia&#xD;
      affects abdominal wall elasticity and effect surgical outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ARFI-SWV Ultrasound holds promise as an inexpensive, noninvasive, point-of-care diagnostic&#xD;
      tool for pre-operatively predicting successful hernia repair. The investigators propose to&#xD;
      develop and refine a quantitative ultrasound protocol to measure abdominal wall features&#xD;
      suitable for predicting successful closure of the midline fascia. ARFI-SWV ultrasound&#xD;
      represents a novel and intriguing modality for real time visualization and characterization&#xD;
      of changes in the biomechanical properties of diseased musculoskeletal tissues.&#xD;
&#xD;
      In this study, ARFI-SWV ultrasound is hypothesized to preoperatively measure the stiffness in&#xD;
      the lateral abdominal wall as an estimation for mobility during hernia repair. Preoperatively&#xD;
      evaluating hernia severity through ARFI-SWV ultrasound will be performed to identify&#xD;
      mechanical characteristics of the abdominal musculature to predict success of midline fascial&#xD;
      re-approximation in hernia patients. The study proposes to compare ultrasound images and&#xD;
      associated shear wave velocity measurements between 35 healthy volunteers and 25 subjects&#xD;
      undergoing surgical repair for ventral hernia. Subjects with ventral hernia will undergo&#xD;
      imaging no earlier than two weeks prior to elective hernia repair and again postoperatively&#xD;
      within six months following repair at a standard followup visit. Statistical analysis will&#xD;
      determine if there is a significant difference in the abdominal wall stiffness, represented&#xD;
      by the ultrasound shear wave velocity measurements, between the healthy subjects and the&#xD;
      subjects with ventral hernia. Further analysis will determine if there is any statistically&#xD;
      significant relationship between abdominal wall stiffness of subjects with ventral hernia and&#xD;
      surgical outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">September 15, 2017</completion_date>
  <primary_completion_date type="Actual">September 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall</measure>
    <time_frame>study intiation ultrasound scan lasting up to 45 minutes</time_frame>
    <description>Differences in the shear wave velocity measurements in the abdominal wall of healthy and ventral hernia patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in Shear Wave Velocity Measurement in the Abdominal Wall Pre and Post Hernia Repair</measure>
    <time_frame>through study completion, an up to 26 weeks postoperative</time_frame>
    <description>Differences in the shear wave velocity measurements in the abdominal wall of preoperative hernia scan and postoperative scan 26 weeks after surgical ventral hernia repair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidental Findings and Ultrasound Safety</measure>
    <time_frame>1 year</time_frame>
    <description>Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Ventral Incisional Hernia</condition>
  <arm_group>
    <arm_group_label>Ventral Hernia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty-five patients diagnosed with ventral hernia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Twenty-five volunteers without ventral hernia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Health Volunteers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity</intervention_name>
    <description>Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)</description>
    <arm_group_label>Active Health Volunteers</arm_group_label>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Ventral Hernia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female between 20-70 years of age&#xD;
&#xD;
          -  healthy volunteer or seeking elective ventral hernia repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Pennsylvania Health System</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <results_first_submitted>September 7, 2018</results_first_submitted>
  <results_first_submitted_qc>March 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 24, 2020</results_first_posted>
  <last_update_submitted>March 11, 2020</last_update_submitted>
  <last_update_submitted_qc>March 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>John Fischer, MD, MPH</investigator_full_name>
    <investigator_title>Assisstant Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Ventral</mesh_term>
    <mesh_term>Incisional Hernia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share individual participant data to outside researchers at the end of the study. Any data shared will be de-identified.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 9, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03043079/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ventral Hernia</title>
          <description>Twenty-One patients diagnosed with ventral hernia&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)</description>
        </group>
        <group group_id="P2">
          <title>Healthy Volunteers</title>
          <description>Fourteen volunteers without ventral hernia&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)</description>
        </group>
        <group group_id="P3">
          <title>Active Health Volunteers</title>
          <description>Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Demographic data and shear wave velocity measurements were taken from each subject</population>
      <group_list>
        <group group_id="B1">
          <title>Ventral Hernia</title>
          <description>Twenty-one patients diagnosed with ventral hernia&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)</description>
        </group>
        <group group_id="B2">
          <title>Healthy Volunteers</title>
          <description>Fourteen volunteers without ventral hernia&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)</description>
        </group>
        <group group_id="B3">
          <title>Active Health Volunteers</title>
          <description>Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)</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="21"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.3" spread="7.9"/>
                    <measurement group_id="B2" value="60.5" spread="5.4"/>
                    <measurement group_id="B3" value="27.0" spread="3.17"/>
                    <measurement group_id="B4" value="48.6" spread="14.7"/>
                  </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="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="22"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </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="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="32"/>
                  </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="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>9L4 No Pressure External Oblique Shear Wave Velocity</title>
          <description>For this measurement, a 9L4 probe is applied to the subjects abdomen without any pressure from the examiner, while the subject is holding end expiration. The shear wave velocity (m/s) is measured along the subject's external oblique muscle.</description>
          <units>meters per second</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.94" lower_limit="1.3" upper_limit="2.8"/>
                    <measurement group_id="B2" value="1.9" lower_limit="1.2" upper_limit="2.83"/>
                    <measurement group_id="B3" value="1.97" lower_limit="1.44" upper_limit="2.89"/>
                    <measurement group_id="B4" value="1.9" lower_limit="1.08" upper_limit="2.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall</title>
        <description>Differences in the shear wave velocity measurements in the abdominal wall of healthy and ventral hernia patients</description>
        <time_frame>study intiation ultrasound scan lasting up to 45 minutes</time_frame>
        <population>21 ventral hernia age and BMI matched to 14 health volunteers with 10 active volunteers</population>
        <group_list>
          <group group_id="O1">
            <title>Ventral Hernia</title>
            <description>Twenty-one patients diagnosed with ventral hernia&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)</description>
          </group>
          <group group_id="O2">
            <title>Healthy Volunteers</title>
            <description>Fourteen volunteers without ventral hernia&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)</description>
          </group>
          <group group_id="O3">
            <title>Active Health Volunteers</title>
            <description>Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall</title>
          <description>Differences in the shear wave velocity measurements in the abdominal wall of healthy and ventral hernia patients</description>
          <population>21 ventral hernia age and BMI matched to 14 health volunteers with 10 active volunteers</population>
          <units>meters per second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.89" spread=".31"/>
                    <measurement group_id="O2" value="1.92" spread=".46"/>
                    <measurement group_id="O3" value="1.89" spread=".13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference in Shear Wave Velocity Measurement in the Abdominal Wall Pre and Post Hernia Repair</title>
        <description>Differences in the shear wave velocity measurements in the abdominal wall of preoperative hernia scan and postoperative scan 26 weeks after surgical ventral hernia repair</description>
        <time_frame>through study completion, an up to 26 weeks postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ventral Hernia</title>
            <description>Twenty-one patients diagnosed with ventral hernia&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Shear Wave Velocity Measurement in the Abdominal Wall Pre and Post Hernia Repair</title>
          <description>Differences in the shear wave velocity measurements in the abdominal wall of preoperative hernia scan and postoperative scan 26 weeks after surgical ventral hernia repair</description>
          <units>meters per second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.726" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidental Findings and Ultrasound Safety</title>
        <description>Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ventral Hernia</title>
            <description>Twenty-one patients diagnosed with ventral hernia&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)&#xD;
No adverse events Related to study. No incidental findings from the Ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Incidental Findings and Ultrasound Safety</title>
          <description>Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging</description>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Hernia patients were followed for adverse events for an average of 12 months. There were seen in the outpatuent clinic following typical standard of care guidelines, which is typically 2 weeks and 3 months. Healthy and active volunteers were followed during the initial ultrasound, up to 45 minutes.</time_frame>
      <desc>Adverse events were defined as any event that harmed subjects related to the study protocol. Adverse events related to the hernia surgery itself were not included in the study adverse events as the surgery plan was not affected by study participation. All subjects got the same surgical care that they would have if they were not enrolled in the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ventral Hernia</title>
          <description>Twenty-one patients diagnosed with ventral hernia&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)&#xD;
No adverse events Related to study</description>
        </group>
        <group group_id="E2">
          <title>Healthy Volunteers</title>
          <description>Fourteen volunteers without ventral hernia&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)&#xD;
No adverse events Related to study</description>
        </group>
        <group group_id="E3">
          <title>Active Health Volunteers</title>
          <description>Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity&#xD;
Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)&#xD;
No adverse events Related to study</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>Serious</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="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Incidental Finding</sub_title>
                <description>Any incidental findings that noted during study related ultrasound and required further clinical workup</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. John P Fischer</name_or_title>
      <organization>University of Pennsylvania</organization>
      <phone>2156627300</phone>
      <email>john.fischer2@uphs.upenn.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/NCT03043079
org study id: 823896
nct id: NCT03043079
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Quantitative radiographic imaging holds promise as a novel and innovative strategy to assess
      ventral hernia patients. Assessing abdominal wall changes surrounding ventral hernia using
      shear wave velocity values measured with ultrasound will identify features of the abdominal
      wall that differ between healthy volunteers and subjects scheduled to have ventral hernia
      repair. Through the use of ultrasound including shear wave velocity measurements, the
      abdominal wall of 25 subjects scheduled to have ventral hernia repair will be compared to
      those of 35 healthy volunteers. The ultrasound measurements will elucidate if ventral hernia
      affects abdominal wall elasticity and effect surgical outcomes.
ARFI-SWV Ultrasound holds promise as an inexpensive, noninvasive, point-of-care diagnostic
      tool for pre-operatively predicting successful hernia repair. The investigators propose to
      develop and refine a quantitative ultrasound protocol to measure abdominal wall features
      suitable for predicting successful closure of the midline fascia. ARFI-SWV ultrasound
      represents a novel and intriguing modality for real time visualization and characterization
      of changes in the biomechanical properties of diseased musculoskeletal tissues.

      In this study, ARFI-SWV ultrasound is hypothesized to preoperatively measure the stiffness in
      the lateral abdominal wall as an estimation for mobility during hernia repair. Preoperatively
      evaluating hernia severity through ARFI-SWV ultrasound will be performed to identify
      mechanical characteristics of the abdominal musculature to predict success of midline fascial
      re-approximation in hernia patients. The study proposes to compare ultrasound images and
      associated shear wave velocity measurements between 35 healthy volunteers and 25 subjects
      undergoing surgical repair for ventral hernia. Subjects with ventral hernia will undergo
      imaging no earlier than two weeks prior to elective hernia repair and again postoperatively
      within six months following repair at a standard followup visit. Statistical analysis will
      determine if there is a significant difference in the abdominal wall stiffness, represented
      by the ultrasound shear wave velocity measurements, between the healthy subjects and the
      subjects with ventral hernia. Further analysis will determine if there is any statistically
      significant relationship between abdominal wall stiffness of subjects with ventral hernia and
      surgical outcomes.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall
time frame: study intiation ultrasound scan lasting up to 45 minutes
description: Differences in the shear wave velocity measurements in the abdominal wall of healthy and ventral hernia patients
measure: Difference in Shear Wave Velocity Measurement in the Abdominal Wall Pre and Post Hernia Repair
time frame: through study completion, an up to 26 weeks postoperative
description: Differences in the shear wave velocity measurements in the abdominal wall of preoperative hernia scan and postoperative scan 26 weeks after surgical ventral hernia repair
measure: Incidental Findings and Ultrasound Safety
time frame: 1 year
description: Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging
arm group label: Ventral Hernia
arm group type: Experimental
description: Twenty-five patients diagnosed with ventral hernia
arm group label: Healthy Volunteers
arm group type: Other
description: Twenty-five volunteers without ventral hernia
arm group label: Active Health Volunteers
arm group type: Other
description: Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity
intervention type: Diagnostic Test
intervention name: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity
description: Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)
arm group label: Active Health Volunteers
arm group label: Healthy Volunteers
arm group label: Ventral Hernia
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: John Fischer, MD, MPH
investigator title: Assisstant Professor of Surgery
mesh term: Hernia
mesh term: Hernia, Ventral
mesh term: Incisional Hernia
sharing ipd: No
ipd description: There is no plan to share individual participant data to outside researchers at the end of the study. Any data shared will be de-identified.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 