xml: <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/NCT06037525</url>
    </required_header>
    <id_info>
      <org_study_id>MIDLINE</org_study_id>
      <nct_id>NCT06037525</nct_id>
    </id_info>
    <brief_title>Clinical Evaluation of the PowerGlide™ Pro Midline Catheter</brief_title>
    <acronym>Midline</acronym>
    <official_title>Clinical Evaluation of the PowerGlide™ Pro Midline Catheter</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Augsburg</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital Augsburg</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular&#xD;
        diseases&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular&#xD;
        diseases. The selected patients are in need of a long-term i.v. therapy for reasons as&#xD;
        antibiotic therapy or alprostadil therapy. The Midline catheter is a device, which is placed&#xD;
        via Seldinger's technique to a vein usual on the upper extremity under ultrasound-control.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2018</start_date>
    <completion_date type="Actual">May 1, 2023</completion_date>
    <primary_completion_date type="Actual">November 13, 2020</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Dwelling Time</measure>
      <time_frame>0-29 days</time_frame>
      <description>Length of catheter in situ time</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Administration of Alprostadil</measure>
      <time_frame>0-29 days</time_frame>
      <description>Feasibility for the usage of Alprostadil</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Catheter Complications</measure>
      <time_frame>0-29 days</time_frame>
      <description>Site complications as thrombophlebitis and occlusion</description>
    </secondary_outcome>
    <enrollment type="Actual">50</enrollment>
    <condition>Pain</condition>
    <condition>Catheter Infection</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PowerGlide™ Pro Midline Catheter</intervention_name>
      <description>Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular disease</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patients in the vascular surgery department with above mentioned inclusion criteria&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  need for i.v. therapy longer than 7 days&#xD;
  &#xD;
            -  poor peripheral vein status&#xD;
  &#xD;
            -  Administration of alprostadil&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pending dialysis&#xD;
  &#xD;
            -  allergy to catheter material&#xD;
  &#xD;
            -  minor age&#xD;
  &#xD;
            -  life threatening conditions&#xD;
  &#xD;
            -  requirement for central venous catheter&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Alexander Hyhlik-Duerr, PhD</last_name>
      <role>Study Director</role>
      <affiliation>University Hospital Augsburg Vascular Surgery</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University Hospital Augsburg</name>
        <address>
          <city>Augsburg</city>
          <zip>86165</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037525
  org study id: MIDLINE
  nct id: NCT06037525
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular
        diseases
  Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular
        diseases. The selected patients are in need of a long-term i.v. therapy for reasons as
        antibiotic therapy or alprostadil therapy. The Midline catheter is a device, which is placed
        via Seldinger's technique to a vein usual on the upper extremity under ultrasound-control.
  observational model: Cohort
  time perspective: Prospective
  measure: Dwelling Time
  time frame: 0-29 days
  description: Length of catheter in situ time
  measure: Administration of Alprostadil
  time frame: 0-29 days
  description: Feasibility for the usage of Alprostadil
  measure: Catheter Complications
  time frame: 0-29 days
  description: Site complications as thrombophlebitis and occlusion
  intervention type: Device
  intervention name: PowerGlide™ Pro Midline Catheter
  description: Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular disease
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Alexander Hyhlik-Duerr, PhD
  role: Study Director
  affiliation: University Hospital Augsburg Vascular Surgery
  facility: 
  country: Germany
  responsible party type: Sponsor
  sharing ipd: Undecided