<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/NCT03807635</url>
  </required_header>
  <id_info>
    <org_study_id>Test A</org_study_id>
    <nct_id>NCT03807635</nct_id>
  </id_info>
  <brief_title>Simulated Clinical Use Testing on Safety Lancets (Test A)</brief_title>
  <official_title>Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test A)</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 HTL-Strefa's safety lancets&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to evaluate the safety of the use of the safety lancets: ergoLance and&#xD;
      Acti-Lance in the prevention of NSI and to evaluate the user's opinion with regards to the&#xD;
      handling characteristics of the medical devices.&#xD;
&#xD;
      The simulated use clinical study will involve healthcare professionals (HCPs) who routinely&#xD;
      use safety lancets to collect blood samples and lay persons.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">December 13, 2018</completion_date>
  <primary_completion_date type="Actual">December 13, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The true failure rate of the tested devices</measure>
    <time_frame>At time of testing, up to 90 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness of the safety lancet's sharps injury prevention features</measure>
    <time_frame>At time of testing, up to 90 minutes</time_frame>
    <description>Evaluator questionnaire using five-point response Likert scale (coded from 1 &quot;strongly disagree&quot; to 5 &quot;strongly agree&quot;) to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a &quot;greater than&quot; relationship.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective assessments regarding evaluators' interactions with the tested safety lancets</measure>
    <time_frame>At time of testing, up to 90 minutes</time_frame>
    <description>Evaluator questionnaire using five-point response Likert scale (coded from 1 &quot;strongly disagree&quot; to 5 &quot;strongly agree&quot;) to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a &quot;greater than&quot; relationship.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of the devices based on the evaluators' assessments (five-point response scale)</measure>
    <time_frame>At time of testing, up to 90 minutes</time_frame>
    <description>Evaluator questionnaire using five-point response Likert scale (coded from 1 &quot;strongly disagree&quot; to 5 &quot;strongly agree&quot;) to measure any and all observed needlestick injuries and device malfunctions. Numbers assigned to Likert scale express a &quot;greater than&quot; relationship.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Various aspects of the ease of use.</measure>
    <time_frame>At time of testing, up to 90 minutes</time_frame>
    <description>Evaluator questionnaire using five-point response Likert scale (coded from 1 &quot;strongly disagree&quot; to 5 &quot;strongly agree&quot;) to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a &quot;greater than&quot; relationship.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any handling, usability questions / issues associated with the device</measure>
    <time_frame>At time of testing, up to 90 minutes</time_frame>
    <description>Evaluator questionnaire using five-point response Likert scale (coded from 1 &quot;strongly disagree&quot; to 5 &quot;strongly agree&quot;) to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a &quot;greater than&quot; relationship.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Needle Stick</condition>
  <arm_group>
    <arm_group_label>simulation of skin pricking type 450</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The evaluator simulated the capillary blood sampling with the safety lancet type 450</description>
  </arm_group>
  <arm_group>
    <arm_group_label>simulation of skin pricking type 610</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The evaluator simulated the capillary blood sampling with the safety lancet type 610</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ergoLance safety lancet</intervention_name>
    <description>The ergoLance contact activated safety lancets type 450 are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.</description>
    <arm_group_label>simulation of skin pricking type 450</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acti-Lance safety lancet</intervention_name>
    <description>The Acti-Lance safety lancet type 610 is a sterile, single use device used to carry out skin punctures for the purpose of collecting capillary blood samples.</description>
    <arm_group_label>simulation of skin pricking type 610</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA&#xD;
        guidance:&#xD;
&#xD;
          -  (HCP evaluators only) - evaluators who routinely use safety lancets to collect&#xD;
             capillary blood samples (prevention of the learning curve artifacts)&#xD;
&#xD;
          -  evaluators will be United States (US) residents&#xD;
&#xD;
          -  evaluators can read, write, and speak English&#xD;
&#xD;
          -  evaluators are at least 18 years old&#xD;
&#xD;
          -  evaluators are able to understand and provide signed consent for the study&#xD;
&#xD;
          -  evaluators are willing to comply with the study protocol, including being willing to&#xD;
             answer questions and complete questionnaires.&#xD;
&#xD;
          -  evaluators have no concerns about the ability to perform the simulated skin pricking.&#xD;
&#xD;
        Lay person evaluators will have a diverse range of ages (18+ years), socioeconomic&#xD;
        statuses, and race/ethnic backgrounds. UL-Wiklund will recruit some lay person evaluators&#xD;
        with reduced vision and dexterity. Users without safety lancet experience may also be&#xD;
        included in this simulated clinical use study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        HCPs:&#xD;
&#xD;
          -  They do not routinely use safety lancets to collect capillary blood samples,&#xD;
&#xD;
          -  They cannot read, write, and speak English,&#xD;
&#xD;
          -  They or a family member have a business or consulting relationship with a&#xD;
             pharmaceutical or medical device company, or&#xD;
&#xD;
          -  They have participated in a product evaluation or marketing study involving safety&#xD;
             lancets within the last six months&#xD;
&#xD;
        Lay people:&#xD;
&#xD;
          -  They cannot read, write, and speak English,&#xD;
&#xD;
          -  They or a family member have a business or consulting relationship with a&#xD;
             pharmaceutical or medical device company, or&#xD;
&#xD;
          -  They have participated in a product evaluation or marketing study involving safety&#xD;
             lancets within the last six months&#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>UL LLC</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schlesinger Associates</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02116</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 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>needlestick</keyword>
  <keyword>needlestick injury</keyword>
  <keyword>safety lancet</keyword>
  <keyword>sharps injury prevention</keyword>
  <keyword>capillary blood sampling</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/NCT03807635
org study id: Test A
nct id: NCT03807635
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A simulated clinical use testing on the HTL-Strefa's safety lancets
This study aims to evaluate the safety of the use of the safety lancets: ergoLance and
      Acti-Lance in the prevention of NSI and to evaluate the user's opinion with regards to the
      handling characteristics of the medical devices.

      The simulated use clinical study will involve healthcare professionals (HCPs) who routinely
      use safety lancets to collect blood samples and lay persons.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: The true failure rate of the tested devices
time frame: At time of testing, up to 90 minutes
measure: Effectiveness of the safety lancet's sharps injury prevention features
time frame: At time of testing, up to 90 minutes
description: Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.
measure: Subjective assessments regarding evaluators' interactions with the tested safety lancets
time frame: At time of testing, up to 90 minutes
description: Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.
measure: Safety of the devices based on the evaluators' assessments (five-point response scale)
time frame: At time of testing, up to 90 minutes
description: Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure any and all observed needlestick injuries and device malfunctions. Numbers assigned to Likert scale express a "greater than" relationship.
measure: Various aspects of the ease of use.
time frame: At time of testing, up to 90 minutes
description: Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.
measure: Any handling, usability questions / issues associated with the device
time frame: At time of testing, up to 90 minutes
description: Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.
arm group label: simulation of skin pricking type 450
arm group type: Experimental
description: The evaluator simulated the capillary blood sampling with the safety lancet type 450
arm group label: simulation of skin pricking type 610
arm group type: Experimental
description: The evaluator simulated the capillary blood sampling with the safety lancet type 610
intervention type: Device
intervention name: ergoLance safety lancet
description: The ergoLance contact activated safety lancets type 450 are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
arm group label: simulation of skin pricking type 450
intervention type: Device
intervention name: Acti-Lance safety lancet
description: The Acti-Lance safety lancet type 610 is a sterile, single use device used to carry out skin punctures for the purpose of collecting capillary blood samples.
arm group label: simulation of skin pricking type 610
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