<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/NCT03766828</url>
  </required_header>
  <id_info>
    <org_study_id>Vienna-DialysisAccess</org_study_id>
    <nct_id>NCT03766828</nct_id>
  </id_info>
  <brief_title>Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion</brief_title>
  <official_title>Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      A unique inside-out-access technique with a new CE certified device (Surfacer (R) Bluegrass&#xD;
      Vascular, San Antonio, Tx, USA) enables repetitive and confident right-sided placement of&#xD;
      central venous catheters in hemodialysis patients with thoracic central venous occlusion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Achievement of dialysis access</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>procedure related complications</measure>
    <time_frame>3 months</time_frame>
    <description>infections, bleeding, hematoma or pericardial effusions and intervention related parameters</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>Central Venous Catheter Thrombosis</condition>
  <arm_group>
    <arm_group_label>inside-out-access technique with inside-out access device</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>access technique including Sharp recanalization</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>inside-out-access technique with inside-out access device (Surfacer (R))</intervention_name>
    <description>inside-out-access technique with (Surfacer (R)) with a new CE certified device (Surfacer (R), Bluegrass Vascular)</description>
    <arm_group_label>inside-out-access technique with inside-out access device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>access technique including Sharp recanalization</intervention_name>
    <description>access technique with Sharp recanalization via interventional radiology</description>
    <arm_group_label>access technique including Sharp recanalization</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hemodialysis patients with thoracic central venous occlusion requiring vascular access&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with thoracic central venous occlusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gürkan Sengölge</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Medicine III, Division of Nephrology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1180</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>May 27, 2019</last_update_submitted>
  <last_update_submitted_qc>May 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Guerkan SENGOELGE</investigator_full_name>
    <investigator_title>Assoc. Prof. Priv.-Doz. Dr.</investigator_title>
  </responsible_party>
  <keyword>thoracic central venous occlusion</keyword>
  <keyword>Dialysis access</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Upper Extremity Deep Vein Thrombosis</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/NCT03766828
org study id: Vienna-DialysisAccess
nct id: NCT03766828
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A unique inside-out-access technique with a new CE certified device (Surfacer (R) Bluegrass
      Vascular, San Antonio, Tx, USA) enables repetitive and confident right-sided placement of
      central venous catheters in hemodialysis patients with thoracic central venous occlusion.
observational model: Cohort
time perspective: Retrospective
measure: Achievement of dialysis access
time frame: 1 day
measure: procedure related complications
time frame: 3 months
description: infections, bleeding, hematoma or pericardial effusions and intervention related parameters
arm group label: inside-out-access technique with inside-out access device
arm group label: access technique including Sharp recanalization
intervention type: Procedure
intervention name: inside-out-access technique with inside-out access device (Surfacer (R))
description: inside-out-access technique with (Surfacer (R)) with a new CE certified device (Surfacer (R), Bluegrass Vascular)
arm group label: inside-out-access technique with inside-out access device
intervention type: Procedure
intervention name: access technique including Sharp recanalization
description: access technique with Sharp recanalization via interventional radiology
arm group label: access technique including Sharp recanalization
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gürkan Sengölge
role: Principal Investigator
affiliation: Department of Medicine III, Division of Nephrology
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Guerkan SENGOELGE
investigator title: Assoc. Prof. Priv.-Doz. Dr.
mesh term: Thrombosis
mesh term: Upper Extremity Deep Vein Thrombosis