<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/NCT02246504</url>
  </required_header>
  <id_info>
    <org_study_id>HIFU/BG/NT</org_study_id>
    <nct_id>NCT02246504</nct_id>
  </id_info>
  <brief_title>Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.</brief_title>
  <official_title>Registry - 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>
      The purpose of this study is to evaluate thyroid nodule's volume, structure and&#xD;
      vascularisation changes following HIFU therapy assessed by ultrasonography&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HIFU treatment will be performed under conscious sedation under the supervision /&#xD;
      responsibilities of an anesthetist.&#xD;
&#xD;
      A maximum of 2 HIFU sessions per nodule will be performed per patient. The decision to&#xD;
      retreat the patient will be taken at 1 month post-HIFU or later.&#xD;
&#xD;
      Follow-up after HIFU treatment&#xD;
&#xD;
      D1 after HIFU session:&#xD;
&#xD;
        -  Indirect laryngoscopy to check vocal cord mobility.&#xD;
&#xD;
      D7 after HIFU session&#xD;
&#xD;
        -  Clinical examination (skin, local symptoms, oedema, voice….),&#xD;
&#xD;
        -  Ultrasonography and Power Doppler,&#xD;
&#xD;
      M1 after HIFU session&#xD;
&#xD;
        -  Clinical examination (skin, local symptoms, oedema, voice….),&#xD;
&#xD;
        -  Ultrasonography and Power Doppler,&#xD;
&#xD;
      M3 after HIFU session&#xD;
&#xD;
        -  Clinical examination (skin, local symptoms, oedema, voice….),&#xD;
&#xD;
        -  Ultrasonography and Power Doppler Decision for an additional HIFU course to improve&#xD;
           volume reduction.&#xD;
&#xD;
      In case of a second HIFU session D7b, M1b and M3b, M6b, M9b, M12b, M18b, M24b and M36b will&#xD;
      be performed&#xD;
&#xD;
      M6 after last HIFU session&#xD;
&#xD;
        -  Clinical examination (skin, local symptoms, oedema, voice….),&#xD;
&#xD;
        -  Ultrasonography and Power Doppler&#xD;
&#xD;
        -  TSH&#xD;
&#xD;
        -  Free T4&#xD;
&#xD;
        -  Antithyroid peroxidase antibodies&#xD;
&#xD;
        -  Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)&#xD;
&#xD;
      M9 after HIFU session&#xD;
&#xD;
        -  Clinical examination (skin, local symptoms, oedema, voice….),&#xD;
&#xD;
        -  Ultrasonography and Power Doppler&#xD;
&#xD;
      M12 after last HIFU session&#xD;
&#xD;
        -  Clinical examination (skin, local symptoms, oedema, voice….),&#xD;
&#xD;
        -  Ultrasonography and Power Doppler&#xD;
&#xD;
        -  TSH&#xD;
&#xD;
        -  Free T4&#xD;
&#xD;
        -  Antithyroid peroxidase antibodies&#xD;
&#xD;
        -  Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)&#xD;
&#xD;
      M18, M24, M36 after HIFU session&#xD;
&#xD;
        -  Clinical examination (skin, local symptoms, oedema, voice….),&#xD;
&#xD;
        -  Ultrasonography and Power Doppler&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2012</start_date>
  <completion_date type="Actual">March 7, 2017</completion_date>
  <primary_completion_date type="Actual">March 7, 2017</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>Change from baseline in thyroid nodule's volume</measure>
    <time_frame>Month 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in thyroid nodule's structure and vascularisation</measure>
    <time_frame>Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>D1, D7, M1, M3 and M6</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Non-malignant Thyroid Nodule</condition>
  <arm_group>
    <arm_group_label>HIFU treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>use of HIFU treatment in patients with non-malignant thyroid nodules</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HIFU treatment</intervention_name>
    <arm_group_label>HIFU treatment</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 FNAB from the last 6 months&#xD;
&#xD;
               3. Normal serum calcitonin&#xD;
&#xD;
               4. No history of neck irradiation&#xD;
&#xD;
          -  Normal 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;
          -  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 IV neurolept analgesia.&#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>Roussanka Kovatcheva, Prof.</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street</name>
      <address>
        <city>Sofia</city>
        <zip>14031</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>September 13, 2019</last_update_submitted>
  <last_update_submitted_qc>September 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 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/NCT02246504
org study id: HIFU/BG/NT
nct id: NCT02246504
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate thyroid nodule's volume, structure and
      vascularisation changes following HIFU therapy assessed by ultrasonography
HIFU treatment will be performed under conscious sedation under the supervision /
      responsibilities of an anesthetist.

      A maximum of 2 HIFU sessions per nodule will be performed per patient. The decision to
      retreat the patient will be taken at 1 month post-HIFU or later.

      Follow-up after HIFU treatment

      D1 after HIFU session:

        -  Indirect laryngoscopy to check vocal cord mobility.

      D7 after HIFU session

        -  Clinical examination (skin, local symptoms, oedema, voice….),

        -  Ultrasonography and Power Doppler,

      M1 after HIFU session

        -  Clinical examination (skin, local symptoms, oedema, voice….),

        -  Ultrasonography and Power Doppler,

      M3 after HIFU session

        -  Clinical examination (skin, local symptoms, oedema, voice….),

        -  Ultrasonography and Power Doppler Decision for an additional HIFU course to improve
           volume reduction.

      In case of a second HIFU session D7b, M1b and M3b, M6b, M9b, M12b, M18b, M24b and M36b will
      be performed

      M6 after last HIFU session

        -  Clinical examination (skin, local symptoms, oedema, voice….),

        -  Ultrasonography and Power Doppler

        -  TSH

        -  Free T4

        -  Antithyroid peroxidase antibodies

        -  Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)

      M9 after HIFU session

        -  Clinical examination (skin, local symptoms, oedema, voice….),

        -  Ultrasonography and Power Doppler

      M12 after last HIFU session

        -  Clinical examination (skin, local symptoms, oedema, voice….),

        -  Ultrasonography and Power Doppler

        -  TSH

        -  Free T4

        -  Antithyroid peroxidase antibodies

        -  Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)

      M18, M24, M36 after HIFU session

        -  Clinical examination (skin, local symptoms, oedema, voice….),

        -  Ultrasonography and Power Doppler
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in thyroid nodule's volume
time frame: Month 6
measure: Change from baseline in thyroid nodule's structure and vascularisation
time frame: Month 6
measure: Number of participants with adverse events
time frame: D1, D7, M1, M3 and M6
arm group label: HIFU treatment
arm group type: Experimental
description: use of HIFU treatment in patients with non-malignant thyroid nodules
intervention type: Device
intervention name: HIFU treatment
arm group label: HIFU treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roussanka Kovatcheva, Prof.
role: Principal Investigator
facility: 
country: Bulgaria
responsible party type: Sponsor
mesh term: Thyroid Nodule
mesh term: Thyroid Diseases