<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/NCT02997540</url>
  </required_header>
  <id_info>
    <org_study_id>BVN G-1000</org_study_id>
    <nct_id>NCT02997540</nct_id>
  </id_info>
  <brief_title>Effect of Body Position and Probe Position on the Localization of Breast Mass</brief_title>
  <official_title>Evaluation of the Effect of Body Position and Probe Position on the Localization of Breast Mass in Free-Hand Breast Ultrasound Examination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MetriTrack, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MetriTrack, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate that BVN G-1000 can precisely and consistently&#xD;
      measure the position of female breast lesions regardless of patient rotation and probe angle&#xD;
      during ultrasound examination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed research consists of quantitatively detecting and reporting the effect of body&#xD;
      rotation and ultrasound probe position on the breast on the position of breast lesions&#xD;
      relative to the breast nipple and body orientation planes, required for positional&#xD;
      annotations, in female subjects at one study visit. Measurements will be manually and&#xD;
      automatically recorded by two ultrasound operators with each image and will be compared among&#xD;
      these conditions to detect effects of probe position and probe orientation and patient's body&#xD;
      position relative to the exam table. The manual and automated measurements will be compared&#xD;
      to determine the differences between the data obtained using the two different methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Successfully obtained sufficient data to complete this research project.&#xD;
  </why_stopped>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">January 2020</completion_date>
  <primary_completion_date type="Actual">January 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>movement of a given ultrasound breast lesion</measure>
    <time_frame>study completion, an average of 1 day</time_frame>
    <description>movement of a given ultrasound breast lesion between different operators and between different body rotation positions and probe positions and orientations</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Breast Diseases</condition>
  <arm_group>
    <arm_group_label>female breast ultrasound exam</arm_group_label>
    <description>females with at least one benign or probably benign mass, up to 2 cm in size, in one breast, detected during a standard-of-care breast ultrasound examination</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Females of any ethnic group who meet all inclusion and none of the exclusion criteria will&#xD;
        be eligible for enrollment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female&#xD;
&#xD;
          2. 21-70 years of age&#xD;
&#xD;
          3. Known palpable or non-palpable benign or probably benign breast mass or masses, less&#xD;
             than 2 cm in maximum diameter and at least 4 cm away from the nipple, from a previous&#xD;
             ultrasound examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women with cardiac pacemaker or portable defibrillator&#xD;
&#xD;
          2. Women with known breast cancer or suspicious lesions&#xD;
&#xD;
          3. Pregnant and lactating women&#xD;
&#xD;
          4. Women who have breast implant(s)&#xD;
&#xD;
          5. Women who have had prior breast surgical intervention not including breast needle&#xD;
             biopsy, in the same breast with the qualifying target mass.&#xD;
&#xD;
          6. Women with the target finding to be mapped within a distance of 4 cm from patient's&#xD;
             nipple.&#xD;
&#xD;
          7. Women with multiple similar qualifying targets in close proximity (less than 4 cm&#xD;
             between targets).&#xD;
&#xD;
          8. Women with history of allergy to medical-grade adhesive tape or ultrasound gel&#xD;
&#xD;
          9. Women whose weight is over 250 pounds&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Evanston Hospital</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>July 15, 2021</last_update_submitted>
  <last_update_submitted_qc>July 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>female breast lesion</keyword>
  <keyword>ultrasound examination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02997540
org study id: BVN G-1000
nct id: NCT02997540
lead sponsor: 
has dmc: No
The purpose of this study is to demonstrate that BVN G-1000 can precisely and consistently
      measure the position of female breast lesions regardless of patient rotation and probe angle
      during ultrasound examination.
The proposed research consists of quantitatively detecting and reporting the effect of body
      rotation and ultrasound probe position on the breast on the position of breast lesions
      relative to the breast nipple and body orientation planes, required for positional
      annotations, in female subjects at one study visit. Measurements will be manually and
      automatically recorded by two ultrasound operators with each image and will be compared among
      these conditions to detect effects of probe position and probe orientation and patient's body
      position relative to the exam table. The manual and automated measurements will be compared
      to determine the differences between the data obtained using the two different methods.
observational model: Case-Only
time perspective: Prospective
measure: movement of a given ultrasound breast lesion
time frame: study completion, an average of 1 day
description: movement of a given ultrasound breast lesion between different operators and between different body rotation positions and probe positions and orientations
arm group label: female breast ultrasound exam
description: females with at least one benign or probably benign mass, up to 2 cm in size, in one breast, detected during a standard-of-care breast ultrasound examination
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Diseases
sharing ipd: Undecided