<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/NCT03011229</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00077315</org_study_id>
    <nct_id>NCT03011229</nct_id>
  </id_info>
  <brief_title>Endoscopic Ultrasound (EUS) Fine Needle Biopsy (FNB) Submucosal Nodule</brief_title>
  <official_title>Endoscopic Ultrasound Fine Needle Biopsy of Submucosal Lesions of the GI Tract; Finding the Right Needle - A Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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 purpose of this study is to compare the diagnostic accuracy of a novel endoscopic&#xD;
      ultrasound (EUS) biopsy needle to the current standard EUS needle.&#xD;
&#xD;
      The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is&#xD;
      possible for subepithelial lesions (SEL) within the Gastrointestinal (GI) tract versus 60%&#xD;
      yield with the current needle.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Slow enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>diagnostic accuracy of biopsy needle</measure>
    <time_frame>end of biopsy, approximately 10 minutes</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>GI Lesions</condition>
  <arm_group>
    <arm_group_label>Pro Core</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subject is randomized to ProCore standard needle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medtronic Shark Core</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject is randomized to Medtronic Sharkcore needle</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pro Core Needle</intervention_name>
    <description>Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.</description>
    <arm_group_label>Pro Core</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>medtronic Sharkcore Needle</intervention_name>
    <description>Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.</description>
    <arm_group_label>Medtronic Shark Core</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age 18 or older referred for EUS found to have a hypoechoic lesion &gt; 8 mm&#xD;
             within the GI lumen arising from the muscularis propria, as determined by EUS.&#xD;
&#xD;
          -  Women that have a negative pregnant test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18.&#xD;
&#xD;
          -  Uncorrectable coagulopathy (INR&gt;1.5)&#xD;
&#xD;
          -  Uncorrectable thrombocytopenia (platelet count &lt;50,000)&#xD;
&#xD;
          -  Patient who is unable to comply with study requirements&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Female patients who are not tested per our current unit protocol&#xD;
&#xD;
          -  Refusal to consent or unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua Spaete</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>May 6, 2020</last_update_submitted>
  <last_update_submitted_qc>May 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03011229
org study id: Pro00077315
nct id: NCT03011229
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to compare the diagnostic accuracy of a novel endoscopic
      ultrasound (EUS) biopsy needle to the current standard EUS needle.

      The investigators hypothesize that with the SharkcoreTM needle a diagnostic yield of 90% is
      possible for subepithelial lesions (SEL) within the Gastrointestinal (GI) tract versus 60%
      yield with the current needle.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: diagnostic accuracy of biopsy needle
time frame: end of biopsy, approximately 10 minutes
arm group label: Pro Core
arm group type: Active Comparator
description: Subject is randomized to ProCore standard needle.
arm group label: Medtronic Shark Core
arm group type: Experimental
description: Subject is randomized to Medtronic Sharkcore needle
intervention type: Device
intervention name: Pro Core Needle
description: Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.
arm group label: Pro Core
intervention type: Device
intervention name: medtronic Sharkcore Needle
description: Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.
arm group label: Medtronic Shark Core
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joshua Spaete
role: Principal Investigator
affiliation: Duke Health System
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No