<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/NCT03300206</url>
  </required_header>
  <id_info>
    <org_study_id>16-05B</org_study_id>
    <nct_id>NCT03300206</nct_id>
  </id_info>
  <brief_title>A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System</brief_title>
  <official_title>A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hologic, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hologic, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post&#xD;
      biopsy handling all during the same procedure. This post-market clinical trial will be&#xD;
      performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy&#xD;
      System as compared to the current standard-of-care breast biopsy procedures&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Actual">March 19, 2019</completion_date>
  <primary_completion_date type="Actual">March 19, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Procedural Time</measure>
    <time_frame>Through study completion - Data collected from day of Breast Biopsy Procedure Only</time_frame>
    <description>The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system with real time imaging and biopsies performed using the standard-of-care biopsy system at each clinical site.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-biopsy complication rates</measure>
    <time_frame>Through study completion - Data collected from day of Breast Biopsy Procedure Only</time_frame>
    <description>Adverse event rates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total tissue acquisition by number of cores and sample mass,</measure>
    <time_frame>Through study completion - Data collected from day of Breast Biopsy Procedure Only</time_frame>
    <description>Tissue weight and number of cores collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feedback from Radiologist, Technologist and Patient</measure>
    <time_frame>Through study completion - Data collected from day of Breast Biopsy Procedure Only</time_frame>
    <description>Questionnaire Feedback</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">525</enrollment>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>Brevera Breast Biopsy System</arm_group_label>
    <description>The Brevera Breast Biopsy System with CorLumina imaging technology is a vacuum-assisted biopsy device, which is used to remove breast tissue in a minimally invasive manner using stereotactic or tomosynthesis imaging.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <description>Each of the participating sites will currently be using a vacuum assisted breast biopsy system along with a specimen radiography system (or other specimen imaging system).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Breast Biopsy</intervention_name>
    <description>A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous.</description>
    <arm_group_label>Brevera Breast Biopsy System</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Female subjects who require a stereotactic breast biopsy procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female aged 18 years of age or older&#xD;
&#xD;
          -  Subject has at least one breast imaging finding requiring biopsy for which images are&#xD;
             available&#xD;
&#xD;
          -  Subject is able to understand, read and sign the trial specific informed consent form&#xD;
             after the nature of the trial has been fully explained to her&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who, based on the physician's judgment, may be at increased risk or develop&#xD;
             complications associated with core removal or biopsy.&#xD;
&#xD;
          -  Patients receiving anticoagulant therapy or may have bleeding disorders which may put&#xD;
             the patient at increased risk of procedural complications based upon physicians&#xD;
             judgment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only females (biologic) will be eligible for participation in the clinical trial.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>HonorHealth</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kensington Medical Center - Kaiser Permanente</name>
      <address>
        <city>Kensington</city>
        <state>Maryland</state>
        <zip>29895</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elizabeth Wende Breast Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magee-Womens Hospital of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah - Huntsman Cancer Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Biopsy</keyword>
  <keyword>Breast Biopsy Imaging</keyword>
  <keyword>Stereotactic Biopsy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 8, 2022</submitted>
  </pending_results>
  <!-- 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/NCT03300206
org study id: 16-05B
nct id: NCT03300206
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post
      biopsy handling all during the same procedure. This post-market clinical trial will be
      performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy
      System as compared to the current standard-of-care breast biopsy procedures
observational model: Cohort
time perspective: Prospective
measure: Procedural Time
time frame: Through study completion - Data collected from day of Breast Biopsy Procedure Only
description: The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system with real time imaging and biopsies performed using the standard-of-care biopsy system at each clinical site.
measure: Post-biopsy complication rates
time frame: Through study completion - Data collected from day of Breast Biopsy Procedure Only
description: Adverse event rates.
measure: Total tissue acquisition by number of cores and sample mass,
time frame: Through study completion - Data collected from day of Breast Biopsy Procedure Only
description: Tissue weight and number of cores collected
measure: Feedback from Radiologist, Technologist and Patient
time frame: Through study completion - Data collected from day of Breast Biopsy Procedure Only
description: Questionnaire Feedback
arm group label: Brevera Breast Biopsy System
description: The Brevera Breast Biopsy System with CorLumina imaging technology is a vacuum-assisted biopsy device, which is used to remove breast tissue in a minimally invasive manner using stereotactic or tomosynthesis imaging.
arm group label: Standard of Care
description: Each of the participating sites will currently be using a vacuum assisted breast biopsy system along with a specimen radiography system (or other specimen imaging system).
intervention type: Device
intervention name: Breast Biopsy
description: A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous.
arm group label: Brevera Breast Biopsy System
arm group label: Standard of Care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Only females (biologic) will be eligible for participation in the clinical trial.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
submitted: December 8, 2022