<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/NCT03803488</url>
  </required_header>
  <id_info>
    <org_study_id>CIP v1.0 29JAN2016</org_study_id>
    <nct_id>NCT03803488</nct_id>
  </id_info>
  <brief_title>Simulated Clinical Use Testing on the DropSafe Safety Pen Needle</brief_title>
  <official_title>Simulated Clinical Use Testing on the DropSafe Safety Pen Needle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HTL-Strefa S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HTL-Strefa S.A.</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>
      A simulated clinical use testing on the DropSafe safety pen needle&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to evaluate the safety of the use of DropSafe safety pen needle in the&#xD;
      prevention of needle stick injuries (NSI) and to evaluate the user's satisfaction with&#xD;
      regards to the handling characteristics of the product.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2016</start_date>
  <completion_date type="Actual">December 9, 2016</completion_date>
  <primary_completion_date type="Actual">December 9, 2016</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The true failure rate of DropSafe safety pen needle.</measure>
    <time_frame>At time of testing, about an hour</time_frame>
    <description>The failure rate of the safety feature for the DropSafe safety pen needle was estimated using the proportion of devices that fail out of the total tested. Failure was defined as NSI or contact with the needle after injection or non-complete activation of the safety feature.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ease of use</measure>
    <time_frame>At time of testing, about an hour</time_frame>
    <description>Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to follow the instructions for use</measure>
    <time_frame>At time of testing, about an hour</time_frame>
    <description>Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of understanding the instructions for use</measure>
    <time_frame>At time of testing, about an hour</time_frame>
    <description>Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Problems associated with the device</measure>
    <time_frame>At time of testing, about an hour</time_frame>
    <description>Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Needle Stick</condition>
  <arm_group>
    <arm_group_label>simulation of injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DropSafe safety pen needle</intervention_name>
    <arm_group_label>simulation of injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Minimum of age 18.&#xD;
&#xD;
          2. Able to understand and provide signed consent for the study.&#xD;
&#xD;
          3. Willing to comply with the study protocol, including being willing to answer questions&#xD;
             and complete questionnaires.&#xD;
&#xD;
          4. Have no concerns about the ability to perform the simulated injections.&#xD;
&#xD;
          5. Have no financial interest in the sponsor (HTL-Strefa S.A.) or the MRO (NAMSA).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. If in the opinion of the sponsor or MRO, including the observer/monitor, the potential&#xD;
        evaluator is not a good candidate for the study, including for reasons such as mental&#xD;
        health.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>NAMSA</name>
      <address>
        <city>Golden Valley</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NAMSA</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>needlestick</keyword>
  <keyword>needlestick injury</keyword>
  <keyword>pen needle</keyword>
  <keyword>sharps injury prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Needlestick Injuries</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/NCT03803488
org study id: CIP v1.0 29JAN2016
nct id: NCT03803488
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A simulated clinical use testing on the DropSafe safety pen needle
This study aims to evaluate the safety of the use of DropSafe safety pen needle in the
      prevention of needle stick injuries (NSI) and to evaluate the user's satisfaction with
      regards to the handling characteristics of the product.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: The true failure rate of DropSafe safety pen needle.
time frame: At time of testing, about an hour
description: The failure rate of the safety feature for the DropSafe safety pen needle was estimated using the proportion of devices that fail out of the total tested. Failure was defined as NSI or contact with the needle after injection or non-complete activation of the safety feature.
measure: Ease of use
time frame: At time of testing, about an hour
description: Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
measure: Ability to follow the instructions for use
time frame: At time of testing, about an hour
description: Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
measure: Ease of understanding the instructions for use
time frame: At time of testing, about an hour
description: Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
measure: Problems associated with the device
time frame: At time of testing, about an hour
description: Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
arm group label: simulation of injection
arm group type: Experimental
description: The evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange.
intervention type: Device
intervention name: DropSafe safety pen needle
arm group label: simulation of injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Needlestick Injuries