<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/NCT03304834</url>
  </required_header>
  <id_info>
    <org_study_id>HIFU-VV-001</org_study_id>
    <nct_id>NCT03304834</nct_id>
  </id_info>
  <brief_title>Treatment of Insufficient Superficial and Perforating Veins of the Lower Limb Using HIFU</brief_title>
  <acronym>Archimedes01</acronym>
  <official_title>Minimally Invasive Treatment of Insufficient Superficial and Perforating Veins of the Lower Limb Using High Intensity Focused Ultrasound (HIFU): A Single Center Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theraclion</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Theraclion</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-center prospective study with a planned accrual of 35 patients with&#xD;
      diagnosed symptomatic Lower Limb Veins System (Superficial, Perforating) Insufficiency&#xD;
      (including recurrence at the thigh/groin level after previous treatment). The eligible&#xD;
      patients must present a symptomatic Leg Veins System Insufficiency diagnosis which fulfills&#xD;
      the inclusion/exclusion criteria. All patients will be consented at a Pre-Study Visit and&#xD;
      evaluated for eligibility and for baseline characteristics of the disease. Patients will&#xD;
      return to clinic on a separate day for the HIFU treatment. Device performance parameters will&#xD;
      be collected during the HIFU visit. At follow-up visits at 3 days, 7 days and 3 months,&#xD;
      changes in veins and flow characteristics will be evaluated by ultrasound and physical exam,&#xD;
      and patient well-being, including pain and anxiety, will be evaluated by patient-reported VAS&#xD;
      evaluations. Continued follow-up for a total of 3 months will be completed prior to subject&#xD;
      study exit. Adverse events (AE) will be assessed at every study visit following HIFU&#xD;
      treatment. An interim Safety Report will be issued after the first 5 patients will arrive at&#xD;
      the 7 days visit and will be provided to the Ethics Committee. A second report will be issued&#xD;
      once the first 5 patients will complete the follow-up period of 30 days and will be also&#xD;
      provided to the Ethics Committee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Echopulse System provides High Intensity Focused Ultrasound (HIFU) ablation of soft&#xD;
      tissue. The energy is delivered via an extra-corporeal treatment probe, which includes an&#xD;
      imaging system. The high-energy ultrasound waves propagate through the skin and are focused&#xD;
      on a portion of the target tissue, generating intense heat and causing local cell apoptosis&#xD;
      and progressive tissue volume reduction over the following months in the tissue within the&#xD;
      focal area. The process is then repeated in a stepwise fashion to destroy the targeted&#xD;
      tissues.&#xD;
&#xD;
      The Echopulse System is comprised of several components, including the console, treatment arm&#xD;
      containing the visualization and treatment unit (VTU), and computer with touchscreen user&#xD;
      interface. In addition, the Echopulse System is intended to be used in conjunction with a&#xD;
      disposable cooling and coupling system known as EPack.&#xD;
&#xD;
      This is a single-center prospective study with a planned accrual of 35 patients with&#xD;
      diagnosed symptomatic Lower Limb Veins System (Superficial, Perforating) Insufficiency&#xD;
      (including recurrence at the thigh/groin level after previous treatment). The eligible&#xD;
      patients must present a symptomatic Leg Veins System Insufficiency diagnosis which fulfills&#xD;
      the inclusion/exclusion criteria. All patients will be consented at a Pre-Study Visit and&#xD;
      evaluated for eligibility and for baseline characteristics of the disease. Patients will&#xD;
      return to clinic on a separate day for the HIFU treatment. Device performance parameters will&#xD;
      be collected during the HIFU visit. At follow-up visits at 3 days, 7 days and 3 months,&#xD;
      changes in veins and flow characteristics will be evaluated by ultrasound and physical exam,&#xD;
      and patient well-being, including pain and anxiety, will be evaluated by patient-reported VAS&#xD;
      evaluations. Continued follow-up for a total of 3 months will be completed prior to subject&#xD;
      study exit. Adverse events (AE) will be assessed at every study visit following HIFU&#xD;
      treatment. An interim Safety Report will be issued after the first 5 patients will arrive at&#xD;
      the 7 days visit and will be provided to the Ethics Committee. A second report will be issued&#xD;
      once the first 5 patients will complete the follow-up period of 30 days and will be also&#xD;
      provided to the Ethics Committee.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">August 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 30, 2018</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>
    <intervention_model_description>Monocentric study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of venous reflux</measure>
    <time_frame>3 months</time_frame>
    <description>as measured by ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of flow abolition</measure>
    <time_frame>3 months</time_frame>
    <description>As measured by ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergent Adverse Events</measure>
    <time_frame>3 months</time_frame>
    <description>Measure of AEs and SAEs and adjunctive procedures for treating the reflux</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Varicose Ulcer</condition>
  <condition>Veins Diseases</condition>
  <condition>Vein, Varicose</condition>
  <arm_group>
    <arm_group_label>ECHOPULSE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm of patient treated by HIFU</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ECHOPULSE</intervention_name>
    <description>Patient are treated with the HIFU device and the physician is doing a compressive bandage.</description>
    <arm_group_label>ECHOPULSE</arm_group_label>
    <other_name>Compression bandage</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Candidate for venous procedure involving lower limb superficial insufficiency,&#xD;
             recurrence at the thigh/groin level or perforators incompetence.&#xD;
&#xD;
          -  Physical condition allowing ambulation after the procedure.&#xD;
&#xD;
          -  Availability of the patient for all the follow-up visits.&#xD;
&#xD;
          -  Targeted tissue reachable for treatment with the device- meaning between 5mm and 26mm&#xD;
             below the skin surface.&#xD;
&#xD;
          -  Age over 18 years of age at the time of enrollment.&#xD;
&#xD;
          -  No acute venous thrombosis.&#xD;
&#xD;
          -  No complete, or near complete deep vein thrombosis.&#xD;
&#xD;
          -  Patient has signed a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is pregnant or nursing&#xD;
&#xD;
          -  Known allergic reaction to anesthetics to be used&#xD;
&#xD;
          -  Legally incapacitated or imprisoned patients&#xD;
&#xD;
          -  Patient's vein target not clearly visible on the ultrasound images (in B mode) at the&#xD;
             inclusion visit.&#xD;
&#xD;
          -  Patient participating in another clinical trial involving an investigational drug,&#xD;
             device or biologic.&#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>Alfred OBERMAYER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karl Landsteiner Institut für funktionelle Phlebochirurgie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karl Landsteiner Institut für funktionelle Phlebochirurgie</name>
      <address>
        <city>Melk</city>
        <zip>3390</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIFU</keyword>
  <keyword>High intensity focused ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Ulcer</mesh_term>
    <mesh_term>Varicose Veins</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03304834
org study id: HIFU-VV-001
nct id: NCT03304834
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single-center prospective study with a planned accrual of 35 patients with
      diagnosed symptomatic Lower Limb Veins System (Superficial, Perforating) Insufficiency
      (including recurrence at the thigh/groin level after previous treatment). The eligible
      patients must present a symptomatic Leg Veins System Insufficiency diagnosis which fulfills
      the inclusion/exclusion criteria. All patients will be consented at a Pre-Study Visit and
      evaluated for eligibility and for baseline characteristics of the disease. Patients will
      return to clinic on a separate day for the HIFU treatment. Device performance parameters will
      be collected during the HIFU visit. At follow-up visits at 3 days, 7 days and 3 months,
      changes in veins and flow characteristics will be evaluated by ultrasound and physical exam,
      and patient well-being, including pain and anxiety, will be evaluated by patient-reported VAS
      evaluations. Continued follow-up for a total of 3 months will be completed prior to subject
      study exit. Adverse events (AE) will be assessed at every study visit following HIFU
      treatment. An interim Safety Report will be issued after the first 5 patients will arrive at
      the 7 days visit and will be provided to the Ethics Committee. A second report will be issued
      once the first 5 patients will complete the follow-up period of 30 days and will be also
      provided to the Ethics Committee.
The Echopulse System provides High Intensity Focused Ultrasound (HIFU) ablation of soft
      tissue. The energy is delivered via an extra-corporeal treatment probe, which includes an
      imaging system. The high-energy ultrasound waves propagate through the skin and are focused
      on a portion of the target tissue, generating intense heat and causing local cell apoptosis
      and progressive tissue volume reduction over the following months in the tissue within the
      focal area. The process is then repeated in a stepwise fashion to destroy the targeted
      tissues.

      The Echopulse System is comprised of several components, including the console, treatment arm
      containing the visualization and treatment unit (VTU), and computer with touchscreen user
      interface. In addition, the Echopulse System is intended to be used in conjunction with a
      disposable cooling and coupling system known as EPack.

      This is a single-center prospective study with a planned accrual of 35 patients with
      diagnosed symptomatic Lower Limb Veins System (Superficial, Perforating) Insufficiency
      (including recurrence at the thigh/groin level after previous treatment). The eligible
      patients must present a symptomatic Leg Veins System Insufficiency diagnosis which fulfills
      the inclusion/exclusion criteria. All patients will be consented at a Pre-Study Visit and
      evaluated for eligibility and for baseline characteristics of the disease. Patients will
      return to clinic on a separate day for the HIFU treatment. Device performance parameters will
      be collected during the HIFU visit. At follow-up visits at 3 days, 7 days and 3 months,
      changes in veins and flow characteristics will be evaluated by ultrasound and physical exam,
      and patient well-being, including pain and anxiety, will be evaluated by patient-reported VAS
      evaluations. Continued follow-up for a total of 3 months will be completed prior to subject
      study exit. Adverse events (AE) will be assessed at every study visit following HIFU
      treatment. An interim Safety Report will be issued after the first 5 patients will arrive at
      the 7 days visit and will be provided to the Ethics Committee. A second report will be issued
      once the first 5 patients will complete the follow-up period of 30 days and will be also
      provided to the Ethics Committee.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Monocentric study
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction of venous reflux
time frame: 3 months
description: as measured by ultrasound
measure: Measurement of flow abolition
time frame: 3 months
description: As measured by ultrasound
measure: Emergent Adverse Events
time frame: 3 months
description: Measure of AEs and SAEs and adjunctive procedures for treating the reflux
arm group label: ECHOPULSE
arm group type: Experimental
description: Arm of patient treated by HIFU
intervention type: Device
intervention name: ECHOPULSE
description: Patient are treated with the HIFU device and the physician is doing a compressive bandage.
arm group label: ECHOPULSE
other name: Compression bandage
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alfred OBERMAYER, MD
role: Principal Investigator
affiliation: Karl Landsteiner Institut für funktionelle Phlebochirurgie
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Varicose Ulcer
mesh term: Varicose Veins
sharing ipd: No