<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/NCT01726010</url>
  </required_header>
  <id_info>
    <org_study_id>102012</org_study_id>
    <nct_id>NCT01726010</nct_id>
  </id_info>
  <brief_title>22-G-Procore Needle for the Diagnosis of SETs of the Upper GI Tract</brief_title>
  <acronym>PRO-SET</acronym>
  <official_title>Endoscopic Ultrasound Guided Biopsy of Subepithelial Tumors of the Upper Gastrointestinal Tract Using the 22-G-Procore Needle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</source>
  <brief_summary>
    <textblock>
      The goal of this prospective study is to evaluate the feasibility of the 22-G Core Biopsy&#xD;
      Needle with reverse bevel (Procore TM) in biopsy sampling of subepithelial tumors of the&#xD;
      upper gastrointestinal tract.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">October 2013</completion_date>
  <primary_completion_date type="Anticipated">August 2013</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>diagnostic yield</measure>
    <time_frame>6 months</time_frame>
    <description>Number of patients with adequate tissue sample (which allows definitive diagnosis)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Subepithelial Tumors of the Upper Gastrointestinal Tract</condition>
  <arm_group>
    <arm_group_label>22-G Procore Needle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>22-G Procore Needle</intervention_name>
    <arm_group_label>22-G Procore Needle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient age 18 years and older&#xD;
&#xD;
          2. All patients with subepithelial tumors of the upper GI tract (maximum size: 3 cm)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to obtain informed consent&#xD;
&#xD;
          2. ASA class 4 or 5&#xD;
&#xD;
          3. known pregnancy&#xD;
&#xD;
          4. contraindication endoscopy&#xD;
&#xD;
          5. contraindication for taking biopsies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Klinikum rechts der Isar</name>
      <address>
        <city>München</city>
        <state>Bavaria</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefan von Delius, MD</last_name>
      <email>stefan_ruckert@yahoo.de</email>
    </contact>
    <contact_backup>
      <last_name>Christoph Schlag, MD</last_name>
      <email>Christoph.Schlag@lrz.tum.de</email>
    </contact_backup>
    <investigator>
      <last_name>Stefan von Delius, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christoph Schlag, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gregor Weirich, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>November 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>November 8, 2012</last_update_submitted>
  <last_update_submitted_qc>November 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT01726010
org study id: 102012
nct id: NCT01726010
lead sponsor: 
The goal of this prospective study is to evaluate the feasibility of the 22-G Core Biopsy
      Needle with reverse bevel (Procore TM) in biopsy sampling of subepithelial tumors of the
      upper gastrointestinal tract.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: diagnostic yield
time frame: 6 months
description: Number of patients with adequate tissue sample (which allows definitive diagnosis)
arm group label: 22-G Procore Needle
arm group type: Experimental
intervention type: Device
intervention name: 22-G Procore Needle
arm group label: 22-G Procore Needle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Germany
responsible party type: Sponsor