<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/NCT01663493</url>
  </required_header>
  <id_info>
    <org_study_id>2012-P-000955/1</org_study_id>
    <nct_id>NCT01663493</nct_id>
  </id_info>
  <brief_title>Comparing Methods to Biopsy Pancreas Mass</brief_title>
  <official_title>Randomized Trial Comparing 2 Needles During EUS-FNA of Solid Pancreatic Masses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine whether there is any difference in number of passes needed to&#xD;
      diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different&#xD;
      types of needles.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>number of passes</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Pancreas Mass Diagnosis</condition>
  <arm_group>
    <arm_group_label>Fine needle aspiration needle</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>standard Beacon FNA needle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fine needle biopsy needle</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>SharkCore fine needle biopsy needle</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FNB</intervention_name>
    <arm_group_label>Fine needle aspiration needle</arm_group_label>
    <arm_group_label>fine needle biopsy needle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult&#xD;
&#xD;
          -  pancreas mass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  mass not approachable by endoscopic ultrasound biopsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda S Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>February 11, 2017</last_update_submitted>
  <last_update_submitted_qc>February 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Linda S. Lee</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <!-- 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/NCT01663493
org study id: 2012-P-000955/1
nct id: NCT01663493
lead sponsor: 
has dmc: No
This study will examine whether there is any difference in number of passes needed to
      diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different
      types of needles.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: number of passes
time frame: 1 week
arm group label: Fine needle aspiration needle
arm group type: Other
description: standard Beacon FNA needle
arm group label: fine needle biopsy needle
arm group type: Other
description: SharkCore fine needle biopsy needle
intervention type: Procedure
intervention name: FNB
arm group label: Fine needle aspiration needle
arm group label: fine needle biopsy needle
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Linda S Lee
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Linda S. Lee
investigator title: Assistant Professor of Medicine