<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/NCT04458233</url>
  </required_header>
  <id_info>
    <org_study_id>0006-20</org_study_id>
    <nct_id>NCT04458233</nct_id>
  </id_info>
  <brief_title>FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study</brief_title>
  <official_title>FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ziv Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ziv Hospital</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>
      Ultrasound-guided fine needle aspiration cytology (FNAC) has been proven to be an accurate&#xD;
      and efficient tool in thyroid nodule evaluation. Thyroid nodule aspiration is performed by&#xD;
      the use of either two techniques; the short axis approach by which only the tip of the needle&#xD;
      is observed, or the long axis approach by which the entire needle is observed. Controversial&#xD;
      remains of which approach produces better diagnostic adequacy and less non-diagnostic&#xD;
      (Bethesda category I) results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      200 patients presenting electively for thyroid FNA will recruited. Patients will be randomly&#xD;
      assigned to two groups: short axis or long axis FNA. FNA will be performed by a single&#xD;
      physician at the Ziv medical center ENT clinics.&#xD;
&#xD;
      patient group randomization will be performed according to a random number sequence generated&#xD;
      by the SPSS system. Randomization will be performed on admission prior to the procedure.&#xD;
&#xD;
      FNAC sample diagnosis will be performed according to the regular protocol. Laboratory&#xD;
      personnel will be blinded to the sample group.&#xD;
&#xD;
      sample results will be compared and analyzed. A P value of less than 0.05 will be regarded as&#xD;
      significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>amount of FNAC non diagnostic Bethesda 1 results</measure>
    <time_frame>1 year</time_frame>
    <description>The exact preferred technique for performing Ultrasound Guided FNA is unclear. The correct positioning of the US probe and or the FNA needle could have a marked effect on the diagnostic results of the biopsy</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Thyroid Nodule</condition>
  <arm_group>
    <arm_group_label>long axis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>short axis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>long axis FNA method</intervention_name>
    <description>). A &quot;long-axis&quot; view (i.e., a longitudinal image of the needle) is obtained by placing the US probe in a parallel position relative to the course of the needle. Short-axis and long-axis views can be used for both US assistance and guidance of FNA procedure. Correspondingly, approaching the nodule with the needle from the lateral or frontal aspect results in either a long axis or short axis view of the needle on the US screen</description>
    <arm_group_label>long axis</arm_group_label>
    <arm_group_label>short axis</arm_group_label>
    <other_name>short axis FNA method</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  suspected thyroid nodule requiring diagnostic FNA,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under or above age limit, no informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>yaniv avraham</last_name>
    <phone>972-4-6828894</phone>
    <email>yanivavr1@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ziv Medical Center</name>
      <address>
        <city>Zefat</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leonid Livshits, MD</last_name>
      <email>surger79@gmail.com</email>
    </contact>
    <investigator>
      <last_name>YANIV AVRAHAM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no individual data to be shared</ipd_description>
  </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/NCT04458233
org study id: 0006-20
nct id: NCT04458233
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ultrasound-guided fine needle aspiration cytology (FNAC) has been proven to be an accurate
      and efficient tool in thyroid nodule evaluation. Thyroid nodule aspiration is performed by
      the use of either two techniques; the short axis approach by which only the tip of the needle
      is observed, or the long axis approach by which the entire needle is observed. Controversial
      remains of which approach produces better diagnostic adequacy and less non-diagnostic
      (Bethesda category I) results.
200 patients presenting electively for thyroid FNA will recruited. Patients will be randomly
      assigned to two groups: short axis or long axis FNA. FNA will be performed by a single
      physician at the Ziv medical center ENT clinics.

      patient group randomization will be performed according to a random number sequence generated
      by the SPSS system. Randomization will be performed on admission prior to the procedure.

      FNAC sample diagnosis will be performed according to the regular protocol. Laboratory
      personnel will be blinded to the sample group.

      sample results will be compared and analyzed. A P value of less than 0.05 will be regarded as
      significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: amount of FNAC non diagnostic Bethesda 1 results
time frame: 1 year
description: The exact preferred technique for performing Ultrasound Guided FNA is unclear. The correct positioning of the US probe and or the FNA needle could have a marked effect on the diagnostic results of the biopsy
arm group label: long axis
arm group type: Active Comparator
arm group label: short axis
arm group type: Active Comparator
intervention type: Procedure
intervention name: long axis FNA method
description: ). A "long-axis" view (i.e., a longitudinal image of the needle) is obtained by placing the US probe in a parallel position relative to the course of the needle. Short-axis and long-axis views can be used for both US assistance and guidance of FNA procedure. Correspondingly, approaching the nodule with the needle from the lateral or frontal aspect results in either a long axis or short axis view of the needle on the US screen
arm group label: long axis
arm group label: short axis
other name: short axis FNA method
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: yaniv avraham
phone: 972-4-6828894
email: yanivavr1@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Thyroid Nodule
sharing ipd: No
ipd description: no individual data to be shared