<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/NCT03022695</url>
  </required_header>
  <id_info>
    <org_study_id>HIFU 1.0</org_study_id>
    <nct_id>NCT03022695</nct_id>
  </id_info>
  <brief_title>Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)</brief_title>
  <acronym>HIFU</acronym>
  <official_title>Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Women's Hospital Tübingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Theraclion</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Women's Hospital Tübingen</source>
  <brief_summary>
    <textblock>
      This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate&#xD;
      the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>The efficacy is assessed by a reduction in volume of the fibroadenoma at baseline, 6 months and at 12 months after the HIFU on the ultrasonography.</measure>
    <time_frame>Baseline, 6 months, 12 months</time_frame>
    <description>A reduction in volume of &gt; 65% compared to baseline, or a total regression of the fibroadenoma will be taken as effective treatment. The results will be analyzed descriptively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Energy setting to obtain reduction in volume or total regression of the fibroadenoma at 12 months follow-up</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lack of palpable lesion</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain free if pain at baseline (pain related to the fibroadenoma)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gland vascularisation (compared to baseline) power Doppler at day 7, month 6 and 12 after the HIFU session</measure>
    <time_frame>Day 7, month 6, month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain during the HIFU session using a Visual Analog Pain Scale</measure>
    <time_frame>0 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histological outcome through core needle biopsy after 12 month</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality and ease of use of breast immobilization</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Breast Fibroadenoma</condition>
  <arm_group>
    <arm_group_label>Treatment with high-intensity focused ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High Intensity Focused Ultrasound</intervention_name>
    <arm_group_label>Treatment with high-intensity focused ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients 18 years or older with at least one diagnosed breast fibroadenoma.&#xD;
             Diagnosis of fibroadenoma must be based on:&#xD;
&#xD;
          -  clinical examination,&#xD;
&#xD;
          -  women ≤ 40 years of age: ultrasound image alone; women &gt; 40 years of age: ultrasound&#xD;
             image and mammogram,&#xD;
&#xD;
          -  histological confirmation of fibroadenoma of the breast. Patient's fibroadenoma size&#xD;
             as determined by ultrasound imaging: the longest diameter is limited to 25 mm. Women&#xD;
             of childbearing potential must have a negative urine pregnancy test within 72 hours&#xD;
             prior to HIFU treatment. Patient must be able to understand the nature and the extent&#xD;
             of the study and the procedures required and be willing and able to complete the&#xD;
             screening and study procedures. Patient must give written informed consent (personally&#xD;
             signed and dated) before completing any study-related procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who is pregnant or breast-feeding.&#xD;
&#xD;
          -  Patient with history of ipsilateral breast cancer within 5 years prior to study&#xD;
             inclusion or radio therapy to the target breast within 5 years prior to study&#xD;
             inclusion.&#xD;
&#xD;
          -  Patient with implant on the treated breast.&#xD;
&#xD;
          -  Patient with target fibroadenoma pre-treated by cryoablation or interstitial laser&#xD;
             therapy within 12 month before recruiting for HIFU.&#xD;
&#xD;
          -  Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the&#xD;
             inclusion visit. Patient participating in other studies using drugs or medical devices&#xD;
             within 3 months prior to study inclusion or during study participation including the&#xD;
             follow-up period.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department for Women's Health</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 1, 2015</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</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>Fibroadenoma</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/NCT03022695
org study id: HIFU 1.0
nct id: NCT03022695
lead sponsor: 
collaborator: 
This is a monocenter, open-label, uncontrolled study in accordance with §23b MPG to evaluate
      the efficacy of the HIFU-treatment of fibroadenoma using the TH-One device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The efficacy is assessed by a reduction in volume of the fibroadenoma at baseline, 6 months and at 12 months after the HIFU on the ultrasonography.
time frame: Baseline, 6 months, 12 months
description: A reduction in volume of > 65% compared to baseline, or a total regression of the fibroadenoma will be taken as effective treatment. The results will be analyzed descriptively
measure: Energy setting to obtain reduction in volume or total regression of the fibroadenoma at 12 months follow-up
time frame: 1 year
measure: Lack of palpable lesion
time frame: 2 years
measure: Pain free if pain at baseline (pain related to the fibroadenoma)
time frame: 1 year
measure: Gland vascularisation (compared to baseline) power Doppler at day 7, month 6 and 12 after the HIFU session
time frame: Day 7, month 6, month 12
measure: Pain during the HIFU session using a Visual Analog Pain Scale
time frame: 0 month
measure: Histological outcome through core needle biopsy after 12 month
time frame: 1 year
measure: Quality and ease of use of breast immobilization
time frame: 1 year
arm group label: Treatment with high-intensity focused ultrasound
arm group type: Experimental
intervention type: Device
intervention name: High Intensity Focused Ultrasound
arm group label: Treatment with high-intensity focused ultrasound
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Fibroadenoma