<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/NCT03808116</url>
  </required_header>
  <id_info>
    <org_study_id>EMC-0124-18</org_study_id>
    <nct_id>NCT03808116</nct_id>
  </id_info>
  <brief_title>Evaluation of the SmartBx System for Breast Biopsy</brief_title>
  <official_title>Evaluation of the SmartBx System for Breast Biopsy Download While Keeping the Orientation, Unfolding and Unity of the Sample</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UC Care, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UC Care, Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Performance evaluation of a novel, semi-automated device and method for needle core biopsy&#xD;
      download compared to standard methods in terms of:&#xD;
&#xD;
      3. Biopsy core length obtained (i.e. collecting all tissue fragments) 4. Biopsy core yield&#xD;
      (i.e. percent of tissue loss during the pathologic processing)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Examination procedure:&#xD;
&#xD;
        -  Biopsy cores will be collected from the breast during US guided biopsy procedure.&#xD;
&#xD;
        -  The number of cores taken will be decided per the physician discretion according to the&#xD;
           clinical demand.&#xD;
&#xD;
        -  Additional two biopsy core will be taken the SmartBx cassette. Since the SmartBx&#xD;
           cassette holds two biopsies together, two consecutive cores will be collected using the&#xD;
           SmartBx.&#xD;
&#xD;
        -  samples will be photographed for measurements in 2 steps during the process:&#xD;
&#xD;
             1. On the needle notch [A].&#xD;
&#xD;
             2. On the glass slide [B].&#xD;
&#xD;
        -  Standard tissue fixation, processing of the samples in paraffin will be performed&#xD;
           unchanged per the pathology laboratory protocols.&#xD;
&#xD;
        -  Embedding of the biopsy cores taken with the SmartBx will be embedded using the SmartBx&#xD;
           mold and tamper.&#xD;
&#xD;
        -  Standard staining and histology analysis will be preformed to the sectioned samples,&#xD;
           unchanged per the pathology protocols.&#xD;
&#xD;
           • Analysis will be preformed to the histological results, and a comparison between the&#xD;
           standard procedures samples to the SmartBx samples will be performed in terms of -&#xD;
&#xD;
        -  Biopsy core length obtained (i.e. collecting all tissue fragments)&#xD;
&#xD;
        -  Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2019</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">August 5, 2019</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>biopsy core length</measure>
    <time_frame>1 month</time_frame>
    <description>biopsy core length will be measured on the glass slide</description>
  </primary_outcome>
  <primary_outcome>
    <measure>biopsy core yield</measure>
    <time_frame>1 month</time_frame>
    <description>biopsy core length will be measured on the needle and on the glass slide and for each core the length on the slide will be computed in reference to the length on the needle</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>SmartBx biopsy collection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Biopsy cores will be collected from the breast during US guided biopsy procedure.&#xD;
The number of cores taken will be decided per the physician discretion according to the clinical demand.&#xD;
Additional two biopsy core will be taken the SmartBx cassette</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SmartBx</intervention_name>
    <description>he SmartBx device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation.&#xD;
The SmartBx is used as an aiding tool in biopsy procedures. When operated in conjunction with the standard equipment in a prostate biopsy procedure, the SmartBx may be used for the following:&#xD;
To preserve sample unity, including core fragments in their original location along the needle notch.&#xD;
Avoid sample damaging during sample removal from the needle and the following pathology process.</description>
    <arm_group_label>SmartBx biopsy collection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Planned for breast biopsy procedure.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        o Patient's unwilling to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Haemek medical center</name>
      <address>
        <city>Afula</city>
        <state>North Region</state>
        <zip>1834111</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast biopsy</keyword>
  <!-- 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/NCT03808116
org study id: EMC-0124-18
nct id: NCT03808116
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Performance evaluation of a novel, semi-automated device and method for needle core biopsy
      download compared to standard methods in terms of:

      3. Biopsy core length obtained (i.e. collecting all tissue fragments) 4. Biopsy core yield
      (i.e. percent of tissue loss during the pathologic processing)
Examination procedure:

        -  Biopsy cores will be collected from the breast during US guided biopsy procedure.

        -  The number of cores taken will be decided per the physician discretion according to the
           clinical demand.

        -  Additional two biopsy core will be taken the SmartBx cassette. Since the SmartBx
           cassette holds two biopsies together, two consecutive cores will be collected using the
           SmartBx.

        -  samples will be photographed for measurements in 2 steps during the process:

             1. On the needle notch [A].

             2. On the glass slide [B].

        -  Standard tissue fixation, processing of the samples in paraffin will be performed
           unchanged per the pathology laboratory protocols.

        -  Embedding of the biopsy cores taken with the SmartBx will be embedded using the SmartBx
           mold and tamper.

        -  Standard staining and histology analysis will be preformed to the sectioned samples,
           unchanged per the pathology protocols.

           • Analysis will be preformed to the histological results, and a comparison between the
           standard procedures samples to the SmartBx samples will be performed in terms of -

        -  Biopsy core length obtained (i.e. collecting all tissue fragments)

        -  Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: biopsy core length
time frame: 1 month
description: biopsy core length will be measured on the glass slide
measure: biopsy core yield
time frame: 1 month
description: biopsy core length will be measured on the needle and on the glass slide and for each core the length on the slide will be computed in reference to the length on the needle
arm group label: SmartBx biopsy collection
arm group type: Experimental
description: Biopsy cores will be collected from the breast during US guided biopsy procedure.
The number of cores taken will be decided per the physician discretion according to the clinical demand.
Additional two biopsy core will be taken the SmartBx cassette
intervention type: Device
intervention name: SmartBx
description: he SmartBx device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation.
The SmartBx is used as an aiding tool in biopsy procedures. When operated in conjunction with the standard equipment in a prostate biopsy procedure, the SmartBx may be used for the following:
To preserve sample unity, including core fragments in their original location along the needle notch.
Avoid sample damaging during sample removal from the needle and the following pathology process.
arm group label: SmartBx biopsy collection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Israel
responsible party type: Sponsor