<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/NCT01692405</url>
  </required_header>
  <id_info>
    <org_study_id>0086-12-EMC</org_study_id>
    <nct_id>NCT01692405</nct_id>
  </id_info>
  <brief_title>Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample</brief_title>
  <official_title>Semi-automatic Download of Prostate Biopsy Cores 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>
    <has_dmc>No</has_dmc>
  </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;
        1. Biopsy core length obtained (i.e. collecting all tissue fragments)&#xD;
&#xD;
        2. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)&#xD;
&#xD;
        3. Pathologist interpretability&#xD;
&#xD;
        4. Processing time&#xD;
&#xD;
        5. Prostate cancer detection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 29, 2013</start_date>
  <completion_date type="Actual">April 24, 2017</completion_date>
  <primary_completion_date type="Actual">April 5, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percent of tissue loss</measure>
    <time_frame>1 year</time_frame>
    <description>percent of biopsy tissue loss during pathologic processing. comparing the core length as recorded on the biopsy needle notch and on the histology slide</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>prostate cancer detection rate</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>processing time</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">436</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Standard method</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard method- shaking the biopsy needle into a formalin container.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Download onto a biopsy sponge pad</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Samples will be downloaded by moving the needle notch on a biopsy sponge pad.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dowloading the biopsy cores using NavigoBx system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Downloading the biopsy cores using NavigoBx™ system. The NaviGoBx™ device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NaviGo Bx™</intervention_name>
    <description>The NaviGoBx™ system is a device and method that enables an accurate reporting of the exact longitudinal location and direction of the biopsy specimen along the needle notch as well as the accurate length of the specimen. Acquiring this information during the biopsy extraction session provides an accurate designation of the location of any later region of interest within the specimen itself to the longitudinal position along the needle mandrel.</description>
    <arm_group_label>Dowloading the biopsy cores using NavigoBx system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>biopsy sponge pad</intervention_name>
    <description>the biopsy core is downloaded onto a biopsy sponge pad which is than entered into a biopsy cassette.</description>
    <arm_group_label>Download onto a biopsy sponge pad</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Planned for radical or open prostatectomy operation or Planned for TRUS prostate&#xD;
             biopsy procedure.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's unwilling to participate.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Haemek madical center</name>
      <address>
        <city>Afula</city>
        <zip>18101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <link>
    <url>http://hospitals.clalit.co.il/hospitals/emek/he-il/Pages/homepage.aspx</url>
    <description>Haemek medical center home page</description>
  </link>
  <reference>
    <citation>Obek C, Doganca T, Erdal S, Erdogan S, Durak H. Core length in prostate biopsy: size matters. J Urol. 2012 Jun;187(6):2051-5. doi: 10.1016/j.juro.2012.01.075. Epub 2012 Apr 11.</citation>
    <PMID>22498214</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 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>Prostatic Neoplasms</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/NCT01692405
org study id: 0086-12-EMC
nct id: NCT01692405
lead sponsor: 
has dmc: No
Performance evaluation of a novel, semi-automated device and method for needle core biopsy
      download compared to standard methods in terms of:

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

        2. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)

        3. Pathologist interpretability

        4. Processing time

        5. Prostate cancer detection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: percent of tissue loss
time frame: 1 year
description: percent of biopsy tissue loss during pathologic processing. comparing the core length as recorded on the biopsy needle notch and on the histology slide
measure: prostate cancer detection rate
time frame: 1 year
measure: processing time
time frame: 1 year
arm group label: Standard method
arm group type: No Intervention
description: Standard method- shaking the biopsy needle into a formalin container.
arm group label: Download onto a biopsy sponge pad
arm group type: Active Comparator
description: Samples will be downloaded by moving the needle notch on a biopsy sponge pad.
arm group label: Dowloading the biopsy cores using NavigoBx system
arm group type: Experimental
description: Downloading the biopsy cores using NavigoBx™ system. The NaviGoBx™ device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation.
intervention type: Device
intervention name: NaviGo Bx™
description: The NaviGoBx™ system is a device and method that enables an accurate reporting of the exact longitudinal location and direction of the biopsy specimen along the needle notch as well as the accurate length of the specimen. Acquiring this information during the biopsy extraction session provides an accurate designation of the location of any later region of interest within the specimen itself to the longitudinal position along the needle mandrel.
arm group label: Dowloading the biopsy cores using NavigoBx system
intervention type: Procedure
intervention name: biopsy sponge pad
description: the biopsy core is downloaded onto a biopsy sponge pad which is than entered into a biopsy cassette.
arm group label: Download onto a biopsy sponge pad
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
url: http://hospitals.clalit.co.il/hospitals/emek/he-il/Pages/homepage.aspx
description: Haemek medical center home page
citation: Obek C, Doganca T, Erdal S, Erdogan S, Durak H. Core length in prostate biopsy: size matters. J Urol. 2012 Jun;187(6):2051-5. doi: 10.1016/j.juro.2012.01.075. Epub 2012 Apr 11.
PMID: 22498214
responsible party type: Sponsor
mesh term: Prostatic Neoplasms