<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/NCT02248389</url>
  </required_header>
  <id_info>
    <org_study_id>IUCRO-0474</org_study_id>
    <nct_id>NCT02248389</nct_id>
  </id_info>
  <brief_title>Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses</brief_title>
  <acronym>HIFU-KIDNEY</acronym>
  <official_title>Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SonaCare Medical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity&#xD;
      focused ultrasound to target and ablate tumors. It also does not require piercing the tumor&#xD;
      with a needle as does cryotherapy (Cryo) and radiofrequency (RF) ablation. Cryo and RF also&#xD;
      have high retreatment rates due the finding of untreated tumor on follow-up imaging. Thus,&#xD;
      there is reason to hypothesize that Sonatherm with it's real-time ultrasound imaging feedback&#xD;
      could replace RF and Cryo for the treatment of small renal masses where the invasiveness of&#xD;
      full resection partial nephrectomy is contraindicated due to patient comorbidities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study uses a treat and resect model where ablation is followed by a partial nephrectomy.&#xD;
      This will allow for the ablation to be evaluated for necrosis and targeting accuracy. It will&#xD;
      also ensure cancer safety prior validation of the HIFU device. The applied heat of HIFU&#xD;
      ablation could improve hemostasis and blood loss.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2014</start_date>
  <completion_date type="Actual">June 8, 2015</completion_date>
  <primary_completion_date type="Actual">June 8, 2015</primary_completion_date>
  <phase>Phase 1</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operative and postoperative complications</measure>
    <time_frame>4-months</time_frame>
    <description>Observing complications as defined by the Clavien system (1-5).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Necrosis</measure>
    <time_frame>1-week</time_frame>
    <description>A microscopic analysis will be performed to assess necrosis within the ablation zone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor targeting</measure>
    <time_frame>1-week</time_frame>
    <description>The ablation border beyond the tumor will be measured on pathologic analysis with success being defined as 1-10mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon rated ease of use</measure>
    <time_frame>1-week</time_frame>
    <description>A questionnaire assessing the ease of use of the Sonatherm instrument will be given to the surgeon after each case.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Carcinoma, Renal Cell</condition>
  <arm_group>
    <arm_group_label>Ablation arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each person in study will receive ablation of their renal tumor followed by standard partial nephrectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sonatherm 600i ablation system</intervention_name>
    <description>HIFU ablation of tumor.</description>
    <arm_group_label>Ablation arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 18 years of age.&#xD;
&#xD;
          2. Must provide written informed consent&#xD;
&#xD;
          3. Must have presence of an enhancing solid renal mass ≤ 3.0 cm on CT or MRI&#xD;
&#xD;
          4. Must be scheduled for laparoscopic robot assisted partial nephrectomy of renal mass.&#xD;
&#xD;
          5. Must have an expected survival status of at least 3 months.&#xD;
&#xD;
          6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.&#xD;
&#xD;
          7. Previous chemotherapy, and/or biological therapy for cancer are permitted. The subject&#xD;
             should have recovered from the effects of these or of any prior surgery.&#xD;
&#xD;
          8. Women of child bearing potential must have negative pregnancy test (urine or serum)&#xD;
             prior to study enrollment. Females must agree to adequate birth control if conception&#xD;
             is possible during the study.&#xD;
&#xD;
          9. All toxicities from prior therapy must be recovered to a grade 1 or better according&#xD;
             to the Clavien-Dindo Classification system.&#xD;
&#xD;
         10. If previous biopsy of mass has been done, pathology must be consistent with renal cell&#xD;
             carcinoma (RCC).&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. &lt; 90% solid component of the tumor on screening cross-sectional imaging (CT/MRI)&#xD;
&#xD;
          2. Prior ablative or surgical treatment of the lesion&#xD;
&#xD;
          3. Masses located close to the hilar vessels or at locations that cannot be accessed with&#xD;
             the HIFU probe&#xD;
&#xD;
          4. The patient has only one kidney&#xD;
&#xD;
          5. Multiple or bilateral renal masses&#xD;
&#xD;
          6. Failure to meet the following laboratory levels on preoperative screening:&#xD;
&#xD;
               1. Platelet count ≥ 100,000 mm3&#xD;
&#xD;
               2. Hemoglobin ≥ 10 g/dl.&#xD;
&#xD;
               3. Prothrombin Time (PT) ≤ 1.5 times upper limit of laboratory normal (ULN).&#xD;
&#xD;
               4. Activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN.&#xD;
&#xD;
               5. Serum creatinine &lt; 2.5 times ULN.&#xD;
&#xD;
          7. Hepatic toxicity grade 2 (using CTCAE version 4 standard definitions)&#xD;
&#xD;
          8. Inability to hold anticoagulation for surgery due to high risk of a cerebral vascular&#xD;
             event, myocardial event, or like risk (ASA may be continued)&#xD;
&#xD;
          9. Abdominal obesity that would, in the assessment of the PI, make the HIFU ablation&#xD;
             difficult&#xD;
&#xD;
         10. Participation in another investigational trial concurrently or within 30 days prior to&#xD;
             enrollment&#xD;
&#xD;
         11. Subjects with a diagnosis of metastatic disease who are currently receiving treatment&#xD;
             or who are not in remission&#xD;
&#xD;
         12. Significant acute or chronic medical, neurologic, or psychiatric illness in the&#xD;
             subject that, in the judgment of the Principal Investigator, could compromise subject&#xD;
             safety, limit the subject's ability to complete the study, and/or compromise the&#xD;
             objectives of the study&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IU Health University Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>March 21, 2019</last_update_submitted>
  <last_update_submitted_qc>March 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Chandru Sundaram</investigator_full_name>
    <investigator_title>Professor of Urology, Director of Minimally Invasive Surgery</investigator_title>
  </responsible_party>
  <keyword>carcinoma, renal cell</keyword>
  <keyword>ablation</keyword>
  <keyword>laparoscopic surgery</keyword>
  <keyword>high intensity focused ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02248389
org study id: IUCRO-0474
nct id: NCT02248389
lead sponsor: 
collaborator: 
has dmc: Yes
The Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity
      focused ultrasound to target and ablate tumors. It also does not require piercing the tumor
      with a needle as does cryotherapy (Cryo) and radiofrequency (RF) ablation. Cryo and RF also
      have high retreatment rates due the finding of untreated tumor on follow-up imaging. Thus,
      there is reason to hypothesize that Sonatherm with it's real-time ultrasound imaging feedback
      could replace RF and Cryo for the treatment of small renal masses where the invasiveness of
      full resection partial nephrectomy is contraindicated due to patient comorbidities.
This study uses a treat and resect model where ablation is followed by a partial nephrectomy.
      This will allow for the ablation to be evaluated for necrosis and targeting accuracy. It will
      also ensure cancer safety prior validation of the HIFU device. The applied heat of HIFU
      ablation could improve hemostasis and blood loss.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Operative and postoperative complications
time frame: 4-months
description: Observing complications as defined by the Clavien system (1-5).
measure: Necrosis
time frame: 1-week
description: A microscopic analysis will be performed to assess necrosis within the ablation zone.
measure: Tumor targeting
time frame: 1-week
description: The ablation border beyond the tumor will be measured on pathologic analysis with success being defined as 1-10mm.
measure: Surgeon rated ease of use
time frame: 1-week
description: A questionnaire assessing the ease of use of the Sonatherm instrument will be given to the surgeon after each case.
arm group label: Ablation arm
arm group type: Experimental
description: Each person in study will receive ablation of their renal tumor followed by standard partial nephrectomy.
intervention type: Device
intervention name: Sonatherm 600i ablation system
description: HIFU ablation of tumor.
arm group label: Ablation arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Chandru Sundaram
investigator title: Professor of Urology, Director of Minimally Invasive Surgery
mesh term: Carcinoma, Renal Cell