<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/NCT01704170</url>
  </required_header>
  <id_info>
    <org_study_id>KM12-001</org_study_id>
    <nct_id>NCT01704170</nct_id>
  </id_info>
  <brief_title>Feasibility Study to Evaluate Renal Denervation Using Focused Ultrasound</brief_title>
  <official_title>A Feasibility Study: An Evaluation of Renal Denervation Using Externally Focused Therapeutic Ultrasound on Patients With Refractory Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kona Medical Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kona Medical Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, multi-center trial wherein each included subject will receive&#xD;
      the experimental externally focused ultrasound renal denervation therapy. It will be&#xD;
      conducted on a maximum of fifty patients who meet the inclusion and exclusion criteria and&#xD;
      have signed the informed consent form. Safety is the primary endpoint of this study and will&#xD;
      be assessed by incidence and evaluation of any serious adverse effects associated with the&#xD;
      investigational procedure through the 52-week evaluation. Clinical utility is the secondary&#xD;
      endpoint of this study and will be evaluated by assessing pre and post therapy systolic and&#xD;
      diastolic blood pressure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Safety: Incidence of Adverse Events through 52 week follow-up</measure>
    <time_frame>One Year</time_frame>
    <description>Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation of bilateral treatment. Included in this assessment will be the proportion of subjects with any of the following outcomes: (1) death, or (2) medical morbidity, including but not limited to renal artery aneurysm, stenosis, significant deterioration of renal function, fistulae or ureteral stenosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decrease in Blood Pressure</measure>
    <time_frame>12 and 24 weeks post therapy</time_frame>
    <description>Clinical utility will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Renal Denervation Using Externally Focused Ultrasound Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Kona Externally Focused Ultrasound Therapy</intervention_name>
    <arm_group_label>Renal Denervation Using Externally Focused Ultrasound Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is at least 18 years of age.&#xD;
&#xD;
          -  Subject has systolic blood pressure of 160 mmHg in average or greater.&#xD;
&#xD;
          -  Subject has refractory, stable hypertension despite being treated with at least three&#xD;
             hypertensive drugs.&#xD;
&#xD;
          -  Subject has two functioning kidneys, defined as eGFR ≥ 45 ml/min.&#xD;
&#xD;
          -  Subject has at least one renal artery on each side which is greater than 4mm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has hydronephrosis as seen on MRA or ultrasound.&#xD;
&#xD;
          -  Subject has renal stenosis greater than 50% based on baseline MRA.&#xD;
&#xD;
          -  Subject has a renal stent or other implant in the region.&#xD;
&#xD;
          -  Subject has kidney stones which are symptomatic and/or greater than 1cm or in the&#xD;
             discretion of the investigator may interfere with treatment.&#xD;
&#xD;
          -  Subject has a history of abdominal surgery within the past six months.&#xD;
&#xD;
          -  Subject has heterogeneities in the kidney such as large cysts or tumors which in the&#xD;
             discretion of the investigator may interfere with treatment.&#xD;
&#xD;
          -  Subject has active pyelonephritis or a history of pyelonephritis which in the&#xD;
             discretion of the investigator may interfere with treatment.&#xD;
&#xD;
          -  Subject has a history of myocardial infarction, unstable angina pectoris, or&#xD;
             cerebrovascular accident within the last six months.&#xD;
&#xD;
          -  Subject has hemodynamically significant valvular heart disease.&#xD;
&#xD;
          -  Subject has an implantable cardioverter defibrillator, pacemaker, neurostimulator or&#xD;
             other device incompatible with MRI.&#xD;
&#xD;
          -  Subject has a body weight &gt; 150 kilograms.&#xD;
&#xD;
          -  Subject has a target treatment depth &gt; 14 cm.&#xD;
&#xD;
          -  Subject is pregnant, nursing or intends to become pregnant during the trial period.&#xD;
&#xD;
          -  Subject is currently enrolled in other potentially confounding research.&#xD;
&#xD;
          -  Subject has any condition that, at the discretion of the investigator, would preclude&#xD;
             participation in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Monash Medical Center</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Anne's University Hospital</name>
      <address>
        <city>Brno</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Na Homolee Hospital</name>
      <address>
        <city>Prague</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Czech Republic</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>April 10, 2015</last_update_submitted>
  <last_update_submitted_qc>April 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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/NCT01704170
org study id: KM12-001
nct id: NCT01704170
lead sponsor: 
has dmc: No
This study is a prospective, multi-center trial wherein each included subject will receive
      the experimental externally focused ultrasound renal denervation therapy. It will be
      conducted on a maximum of fifty patients who meet the inclusion and exclusion criteria and
      have signed the informed consent form. Safety is the primary endpoint of this study and will
      be assessed by incidence and evaluation of any serious adverse effects associated with the
      investigational procedure through the 52-week evaluation. Clinical utility is the secondary
      endpoint of this study and will be evaluated by assessing pre and post therapy systolic and
      diastolic blood pressure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety: Incidence of Adverse Events through 52 week follow-up
time frame: One Year
description: Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation of bilateral treatment. Included in this assessment will be the proportion of subjects with any of the following outcomes: (1) death, or (2) medical morbidity, including but not limited to renal artery aneurysm, stenosis, significant deterioration of renal function, fistulae or ureteral stenosis.
measure: Decrease in Blood Pressure
time frame: 12 and 24 weeks post therapy
description: Clinical utility will be evaluated by assessing pre and post therapy systolic and diastolic blood pressure.
arm group label: Renal Denervation Using Externally Focused Ultrasound Therapy
arm group type: Experimental
intervention type: Device
intervention name: Kona Externally Focused Ultrasound Therapy
arm group label: Renal Denervation Using Externally Focused Ultrasound Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Canada
country: Czech Republic
responsible party type: Sponsor
mesh term: Hypertension