<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/NCT02197013</url>
  </required_header>
  <id_info>
    <org_study_id>HC-O-H-1207</org_study_id>
    <nct_id>NCT02197013</nct_id>
  </id_info>
  <brief_title>Evaluation of Introcan Safety 3 Closed IV Catheter</brief_title>
  <official_title>Evaluation of Introcan Safety 3 Closed IV Catheter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>B. Braun Melsungen AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>B. Braun Melsungen AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Incidence and time of occurrence of blood leakage with the closed intravascular catheter&#xD;
      Introcan Safety 3 in comparison to Introcan Safety&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Frequency and time of occurence of blood leakage</measure>
    <time_frame>Within one minute</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Problems during catheter insertion and fixation of Introcan Safety 3</measure>
    <time_frame>During insertion and fixation of catheter</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Necessity of disconnection of catheter</measure>
    <time_frame>During catheter placement</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Patients in Need for Intravenous Access</condition>
  <arm_group>
    <arm_group_label>Introcan Safety 3</arm_group_label>
    <description>Closed IV Catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Introcan Safety</arm_group_label>
    <description>IV catheter</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in need for intravenous access&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  need for intravenous access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  n. a.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gertrud Haeseler, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>KKRN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KKRN Katholisches Klinikum Ruhrgebiet Nord GmbH (KKRN)</name>
      <address>
        <city>Dorsten</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>August 2, 2023</last_update_submitted>
  <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</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/NCT02197013
org study id: HC-O-H-1207
nct id: NCT02197013
lead sponsor: 
has dmc: No
Incidence and time of occurrence of blood leakage with the closed intravascular catheter
      Introcan Safety 3 in comparison to Introcan Safety
observational model: Cohort
time perspective: Prospective
measure: Frequency and time of occurence of blood leakage
time frame: Within one minute
measure: Problems during catheter insertion and fixation of Introcan Safety 3
time frame: During insertion and fixation of catheter
measure: Necessity of disconnection of catheter
time frame: During catheter placement
arm group label: Introcan Safety 3
description: Closed IV Catheter
arm group label: Introcan Safety
description: IV catheter
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Gertrud Haeseler, Prof.
role: Principal Investigator
affiliation: KKRN
facility: 
country: Germany
responsible party type: Sponsor