<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/NCT03044054</url>
  </required_header>
  <id_info>
    <org_study_id>HIFU/FA/003</org_study_id>
    <nct_id>NCT03044054</nct_id>
  </id_info>
  <brief_title>Treatment of Breast Fibroadenoma Targeted Tissue With HIFU</brief_title>
  <acronym>HIFU-003</acronym>
  <official_title>Treatment of Breast Fibroadenoma Targeted Tissue With High Intensity Focused Ultrasound (HIFU)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theraclion</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Theraclion</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the efficacy and the safety of the HIFU for the treatment of breast&#xD;
      fibroadenoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma.&#xD;
      HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver&#xD;
      a large amount of sound energy to a focal point to rapidly induce tissue heating to&#xD;
      85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted&#xD;
      area.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</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>Pain level assessment</measure>
    <time_frame>12 Months</time_frame>
    <description>visual analog scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety level assessment</measure>
    <time_frame>12 Months</time_frame>
    <description>visual analog scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume assessment</measure>
    <time_frame>12 Months</time_frame>
    <description>Ultrasound measurement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The short (6-item) version of the State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palpability of the breast fibroadenoma</measure>
    <time_frame>inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months</time_frame>
    <description>Physician clinical examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from additional procedures for fibroadenoma of the breast</measure>
    <time_frame>Day 2/3, Day 7, 6 months, 12 months</time_frame>
    <description>Physician assessment concerning the need of additional procedures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Month 6 and Months 12</time_frame>
    <description>Self assessment satisfaction questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints include adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the trial.</measure>
    <time_frame>Day 0, Day 2/3, Day 7, 6 months, 12 months</time_frame>
    <description>Assessment and capture of adverse events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Breast Fibroadenoma</condition>
  <arm_group>
    <arm_group_label>ECHOPULSE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ECHOPULSE HIFU</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ECHOPULSE</intervention_name>
    <description>HIFU Under ultrasound guidance</description>
    <arm_group_label>ECHOPULSE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female patients 18 years or older diagnosed with breast fibroadenoma and presenting at&#xD;
             least one fibroadenoma.&#xD;
&#xD;
          2. Diagnosis of fibroadenoma must be based on:&#xD;
&#xD;
               1. Clinical examination&#xD;
&#xD;
               2. Ultrasound image alone for patients under 35 years old. For women older than 35&#xD;
                  years, a mammogram will be performed in addition to ultrasound. The BI-RADS score&#xD;
                  of this mammogram must be 2 or 3. BI-RADS score of 4 is eligible if biopsy&#xD;
                  indicates fibroadenoma with concordance.&#xD;
&#xD;
               3. Histologic confirmation by core needle biopsy.&#xD;
&#xD;
          3. Patient is a candidate for the surgery.&#xD;
&#xD;
          4. The fibroadenoma treatment volume must be at least 5 mm and no more than 26 mm from&#xD;
             the skin. This criterion should be evaluated immediately prior treatment, once the&#xD;
             breast is immobilized and potentially compressed.&#xD;
&#xD;
          5. The rib cage should not be in the prefocal ultrasound path or behind the target&#xD;
             fibroadenoma (minimum distance from the posterior wall of the fibroadenoma must be at&#xD;
             least 10 mm). This criterion shall be evaluated immediately prior to treatment, once&#xD;
             breast is immobilized and potentially compressed.&#xD;
&#xD;
          6. The fibroadenoma is 1 cm or greater at its largest dimension and no less than 7.5 mm&#xD;
             in the anterior-posterior dimension (measured by ultrasound). Focal point for HIFU&#xD;
             treatment must also be at least 3 mm from any border of the fibroadenoma.&#xD;
&#xD;
          7. Patient's fibroadenoma size is greater or equal to 0.2 cc and less than 10 cc in&#xD;
             volume (measured by ultrasound on the day of the procedure).&#xD;
&#xD;
          8. Fibroadenoma is palpable.&#xD;
&#xD;
          9. Pain ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days&#xD;
&#xD;
         10. Anxiety ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days&#xD;
&#xD;
         11. Patient has signed a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is pregnant or nursing.&#xD;
&#xD;
          2. Presence of calcified fibroadenoma. Calcification will be determined with mammography.&#xD;
             In women &gt; 35 years old, the diagnostic mammogram should be evaluated for&#xD;
             calcification. In women ≤ 35 years old, a single view mammogram of the affected breast&#xD;
             is sufficient for evaluation of calcification. Women ≤ 35 years old will be excluded&#xD;
             based on the findings of calcification on a single view mammogram.&#xD;
&#xD;
          3. Patient with history of breast cancer or history of laser or radiation therapy to the&#xD;
             target breast.&#xD;
&#xD;
          4. Patient with breast implants in the target breast.&#xD;
&#xD;
          5. Patient with a breast cyst within the fibroadenoma to be treated.&#xD;
&#xD;
          6. Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) at the&#xD;
             inclusion visit.&#xD;
&#xD;
          7. Patient participating in another clinical trial involving an investigational drug,&#xD;
             device or biologic.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michel NUTA, MD</last_name>
    <role>Study Director</role>
    <affiliation>Theraclion</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michel NUTA, MD</last_name>
    <phone>633404004</phone>
    <email>michel.nuta@theraclion.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bellevue Hospital Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jocelyn Acosta</last_name>
    </contact>
    <investigator>
      <last_name>Kathie-Ann Joseph, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chloe Chhor, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shubhada Dhage, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New York Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amanda Alonso</last_name>
    </contact>
    <investigator>
      <last_name>Margaret Chen-Seetoo, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore-Einstein Center for Cancer Care</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Prena Etchen</last_name>
    </contact>
    <investigator>
      <last_name>REIG Beatriu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health system</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katie Rea</last_name>
    </contact>
    <investigator>
      <last_name>David Brenin, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carrie Rochmann, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jonathon Nguyen, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>October 18, 2022</last_update_submitted>
  <last_update_submitted_qc>October 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIFU</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibroadenoma</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/NCT03044054
org study id: HIFU/FA/003
nct id: NCT03044054
lead sponsor: 
has dmc: Yes
This study evaluates the efficacy and the safety of the HIFU for the treatment of breast
      fibroadenoma.
Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma.
      HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver
      a large amount of sound energy to a focal point to rapidly induce tissue heating to
      85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted
      area.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain level assessment
time frame: 12 Months
description: visual analog scale
measure: Anxiety level assessment
time frame: 12 Months
description: visual analog scale
measure: Volume assessment
time frame: 12 Months
description: Ultrasound measurement
measure: The short (6-item) version of the State-Trait Anxiety Inventory (STAI)
time frame: inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months
measure: Palpability of the breast fibroadenoma
time frame: inclusion visit (V0), Day 2/3, Day 7, 6 months, 12 months
description: Physician clinical examination
measure: Freedom from additional procedures for fibroadenoma of the breast
time frame: Day 2/3, Day 7, 6 months, 12 months
description: Physician assessment concerning the need of additional procedures
measure: Patient satisfaction
time frame: Month 6 and Months 12
description: Self assessment satisfaction questionnaire
measure: Safety endpoints include adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the trial.
time frame: Day 0, Day 2/3, Day 7, 6 months, 12 months
description: Assessment and capture of adverse events
arm group label: ECHOPULSE
arm group type: Experimental
description: ECHOPULSE HIFU
intervention type: Device
intervention name: ECHOPULSE
description: HIFU Under ultrasound guidance
arm group label: ECHOPULSE
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michel NUTA, MD
role: Study Director
affiliation: Theraclion
last name: Michel NUTA, MD
phone: 633404004
email: michel.nuta@theraclion.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Fibroadenoma
sharing ipd: No