<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/NCT01666145</url>
  </required_header>
  <id_info>
    <org_study_id>12-11-13B</org_study_id>
    <nct_id>NCT01666145</nct_id>
  </id_info>
  <brief_title>Advanced Image Guidance Utilized in Liver Surgery</brief_title>
  <official_title>Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>InnerOptic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Advanced Image Guidance for this study was used during laparoscopic microwave ablation&#xD;
      surgery to help the surgeon accurately place the ablation needle into the tumor of patients&#xD;
      diagnosed with liver cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatocellular carcinoma (HCC) is diagnosed in over 19,000 Americans annually and responsible&#xD;
      for 17,000 deaths. Worldwide, (HCC) is the third leading cause of cancer death.&#xD;
      Hepatocellular carcinoma recurs frequently due to its multi-centric nature, which requires&#xD;
      repeated treatments and often results in progressively fewer treatment options because of&#xD;
      severe underlying liver dysfunction. While surgery offers the best prognosis for such tumors&#xD;
      and lesions, only 10-15% of all patients are candidates for removal by surgical means,&#xD;
      necessitating the exploration of other treatment options. InnerOptic's AIM Guidance System is&#xD;
      designed to alleviate the difficulty in using ultrasound to place a needle. AIM shows the&#xD;
      needle and the ultrasound slice in their locations in 3D on a stereo monitor, making the&#xD;
      spatial relationship between them obvious. AIM also displays the needle trajectory and where&#xD;
      the needle will intersect with the ultrasound image, providing the surgeon with an indication&#xD;
      of where the needle will go, if inserted along the needle shaft. AIM can also render an&#xD;
      ablation volume guide, providing the surgeon with further confirmation that the needle is&#xD;
      placed accurately and providing a volumetric guide regarding the power settings of the&#xD;
      ablation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful Insertion of Ablation Antenna Into Target Lesion</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.</time_frame>
    <description>Once the ablation antenna has been placed into the target lesion, the success or failure of the attempt will be confirmed with conventional ultrasound alone, in two planes. If the placement is deemed successful, the surgeon will commence the ablation of the tumor. If the placement is deemed insufficient, the probe will be removed and another placement will be attempted using conventional guidance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM)</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.</time_frame>
    <description>A subjective grading scale from which the surgeon will provide the relative ease of lesion targeting using Advanced Image Guidance (AIM) and the guidance system; the scale will be numbered 1-5 with one being significantly difficult and five being significantly easy. The percentage of participants with a score of 5 is reported below.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Carcinoma, Hepatocellular</condition>
  <arm_group>
    <arm_group_label>Intraoperative Imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Advanced Image Guidance</intervention_name>
    <description>Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement.</description>
    <arm_group_label>Intraoperative Imaging</arm_group_label>
    <other_name>AIM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals who have hepatocellular carcinoma.&#xD;
&#xD;
          -  Individuals who are candidates for microwave ablation surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who do not have hepatocellular carcinoma.&#xD;
&#xD;
          -  Individuals who are not a candidate for laparoscopic microwave ablation surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David A Iannitti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carolinas Health System</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>May 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <results_first_submitted>February 3, 2015</results_first_submitted>
  <results_first_submitted_qc>July 27, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 27, 2018</results_first_posted>
  <last_update_submitted>April 20, 2022</last_update_submitted>
  <last_update_submitted_qc>April 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatocellular Cancer</keyword>
  <keyword>Hepatocellular Carcinoma</keyword>
  <keyword>Hepatoma</keyword>
  <keyword>Liver Cancer, Adult</keyword>
  <keyword>Liver Cell Carcinoma, Adult</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intraoperative Imaging</title>
          <description>Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.&#xD;
Advanced Image Guidance: Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement.</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_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intraoperative Imaging</title>
          <description>Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.&#xD;
Advanced Image Guidance: Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63" lower_limit="47" upper_limit="77"/>
                  </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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </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="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Successful Insertion of Ablation Antenna Into Target Lesion</title>
        <description>Once the ablation antenna has been placed into the target lesion, the success or failure of the attempt will be confirmed with conventional ultrasound alone, in two planes. If the placement is deemed successful, the surgeon will commence the ablation of the tumor. If the placement is deemed insufficient, the probe will be removed and another placement will be attempted using conventional guidance.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intraoperative Imaging</title>
            <description>Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.&#xD;
Advanced Image Guidance: Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement.</description>
          </group>
        </group_list>
        <measure>
          <title>Successful Insertion of Ablation Antenna Into Target Lesion</title>
          <description>Once the ablation antenna has been placed into the target lesion, the success or failure of the attempt will be confirmed with conventional ultrasound alone, in two planes. If the placement is deemed successful, the surgeon will commence the ablation of the tumor. If the placement is deemed insufficient, the probe will be removed and another placement will be attempted using conventional guidance.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM)</title>
        <description>A subjective grading scale from which the surgeon will provide the relative ease of lesion targeting using Advanced Image Guidance (AIM) and the guidance system; the scale will be numbered 1-5 with one being significantly difficult and five being significantly easy. The percentage of participants with a score of 5 is reported below.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intraoperative Imaging</title>
            <description>Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.&#xD;
Advanced Image Guidance: Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM)</title>
          <description>A subjective grading scale from which the surgeon will provide the relative ease of lesion targeting using Advanced Image Guidance (AIM) and the guidance system; the scale will be numbered 1-5 with one being significantly difficult and five being significantly easy. The percentage of participants with a score of 5 is reported below.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>To hospital discharge, up to one week</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intraoperative Imaging</title>
          <description>Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.&#xD;
Advanced Image Guidance: Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement.</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="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="14"/>
              </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>Principal Investigator</name_or_title>
      <organization>Carolinas Healthcare System</organization>
      <phone>704-446-2772</phone>
      <email>john.martinie@carolinashealthcare.org</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/NCT01666145
org study id: 12-11-13B
nct id: NCT01666145
lead sponsor: 
collaborator: 
has dmc: Yes
Advanced Image Guidance for this study was used during laparoscopic microwave ablation
      surgery to help the surgeon accurately place the ablation needle into the tumor of patients
      diagnosed with liver cancer.
Hepatocellular carcinoma (HCC) is diagnosed in over 19,000 Americans annually and responsible
      for 17,000 deaths. Worldwide, (HCC) is the third leading cause of cancer death.
      Hepatocellular carcinoma recurs frequently due to its multi-centric nature, which requires
      repeated treatments and often results in progressively fewer treatment options because of
      severe underlying liver dysfunction. While surgery offers the best prognosis for such tumors
      and lesions, only 10-15% of all patients are candidates for removal by surgical means,
      necessitating the exploration of other treatment options. InnerOptic's AIM Guidance System is
      designed to alleviate the difficulty in using ultrasound to place a needle. AIM shows the
      needle and the ultrasound slice in their locations in 3D on a stereo monitor, making the
      spatial relationship between them obvious. AIM also displays the needle trajectory and where
      the needle will intersect with the ultrasound image, providing the surgeon with an indication
      of where the needle will go, if inserted along the needle shaft. AIM can also render an
      ablation volume guide, providing the surgeon with further confirmation that the needle is
      placed accurately and providing a volumetric guide regarding the power settings of the
      ablation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful Insertion of Ablation Antenna Into Target Lesion
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
description: Once the ablation antenna has been placed into the target lesion, the success or failure of the attempt will be confirmed with conventional ultrasound alone, in two planes. If the placement is deemed successful, the surgeon will commence the ablation of the tumor. If the placement is deemed insufficient, the probe will be removed and another placement will be attempted using conventional guidance.
measure: Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
description: A subjective grading scale from which the surgeon will provide the relative ease of lesion targeting using Advanced Image Guidance (AIM) and the guidance system; the scale will be numbered 1-5 with one being significantly difficult and five being significantly easy. The percentage of participants with a score of 5 is reported below.
arm group label: Intraoperative Imaging
arm group type: Experimental
description: Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.
intervention type: Device
intervention name: Advanced Image Guidance
description: Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement.
arm group label: Intraoperative Imaging
other name: AIM
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David A Iannitti, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 