<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/NCT02258347</url>
  </required_header>
  <id_info>
    <org_study_id>HIFU/REG/NT</org_study_id>
    <nct_id>NCT02258347</nct_id>
  </id_info>
  <brief_title>HIFU in Patients With Non-malignant Thyroid Nodules</brief_title>
  <official_title>Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid&#xD;
      nodules.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">October 13, 2015</completion_date>
  <primary_completion_date type="Actual">October 13, 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>Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US)</measure>
    <time_frame>Month 6 and Month 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US)</measure>
    <time_frame>Month 6 and Month 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US)</measure>
    <time_frame>Month 6 and Month 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events as a measure of safety and tolerability</measure>
    <time_frame>Day 1, Month 1, Month 3, Month 6 and Month 12</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Non-malignant Thyroid Nodules</condition>
  <arm_group>
    <arm_group_label>Single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Echopulse</intervention_name>
    <arm_group_label>Single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patient 18 years or older.&#xD;
&#xD;
          -  Patient presenting with at least one thyroid nodule with no signs of malignancy:&#xD;
&#xD;
               1. Non suspect clinically and at ultrasonography imaging&#xD;
&#xD;
               2. Benign cytological diagnosis at fine-needle aspiration biopsy (FNAB) from the&#xD;
                  last 6 months&#xD;
&#xD;
               3. Normal serum calcitonin&#xD;
&#xD;
               4. No history of neck irradiation&#xD;
&#xD;
          -  Normal thyroid-stimulating hormone (TSH).&#xD;
&#xD;
          -  Targeted nodule accessible and eligible to HIFU&#xD;
&#xD;
          -  Absence of abnormal vocal cord mobility at laryngoscopy.&#xD;
&#xD;
          -  Nodule diameter ≥ 10mm measured by ultrasound.&#xD;
&#xD;
          -  Nodule volume inferior to 10 cc&#xD;
&#xD;
          -  Composition of the targeted nodule(s) : no more than 30% cystic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Head and/or neck disease that prevents hyperextension of neck.&#xD;
&#xD;
          -  Known history of thyroid cancer or other neoplasias in the neck region.&#xD;
&#xD;
          -  History of neck irradiation.&#xD;
&#xD;
          -  Macrocalcification inducing a shadow in the thyroid significant enough to preclude the&#xD;
             HIFU treatment&#xD;
&#xD;
          -  Posterior position of the nodule if the thickness of the nodule is &lt;15mm&#xD;
&#xD;
          -  Pregnant or lactating woman&#xD;
&#xD;
          -  Any contraindication to the assigned analgesia/anaesthesia.&#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>Andrea Frasoldati, Dr</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Istituto in tecnologie avanzate e modelli assistenziali in oncologia</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</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>Thyroid Nodule</mesh_term>
    <mesh_term>Thyroid Diseases</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/NCT02258347
org study id: HIFU/REG/NT
nct id: NCT02258347
lead sponsor: 
has dmc: No
Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid
      nodules.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US)
time frame: Month 6 and Month 12
measure: Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US)
time frame: Month 6 and Month 12
measure: Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US)
time frame: Month 6 and Month 12
measure: Number of subjects with adverse events as a measure of safety and tolerability
time frame: Day 1, Month 1, Month 3, Month 6 and Month 12
arm group label: Single arm
arm group type: Experimental
intervention type: Device
intervention name: Echopulse
arm group label: Single arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea Frasoldati, Dr
role: Principal Investigator
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Thyroid Nodule
mesh term: Thyroid Diseases