<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/NCT03752229</url>
  </required_header>
  <id_info>
    <org_study_id>02LAN2017</org_study_id>
    <nct_id>NCT03752229</nct_id>
  </id_info>
  <brief_title>Capillary Blood Volume and Pain Perception Obtained in a Process of Puncturing With Different Safety Lancets</brief_title>
  <official_title>A Randomized, Single Blind, Uni-centre Study in Healthy Volunteers, to Determine Capillary Blood Volume and Pain Perception Obtained in a Process of Puncturing With Different Safety Lancets</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>
      The study was a randomized, single blind, uni-center pivotal study in male and female healthy&#xD;
      volunteers, to determine capillary blood volume and pain perception obtained in a process of&#xD;
      puncturing with different safety lancets.&#xD;
&#xD;
      A group of three hundred (300) Caucasian male and female Subjects was randomized (aged &gt; 18&#xD;
      to &lt; 65 years old) who were in good physical and mental condition. The Subjects had 4 (four)&#xD;
      fingers (two fingers from each hand) lanced each with a different type of safety lancet.&#xD;
      Overall, 4 (four) different safety lancets were investigated per each Subject.&#xD;
&#xD;
      Overall, 48 (forty eight) different safety lancets (4 different safety lancets per one&#xD;
      Subject) were investigated, the capillary blood volume and pain were measured.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2017</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 17, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Volume (microliters) of blood in the capillary tube</measure>
    <time_frame>The blood volume was noted after 20 seconds</time_frame>
    <description>The amount of capillary blood volume collected after a single lancing of the fingertip.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume (microliters) of blood in the capillary tube</measure>
    <time_frame>The blood volume was noted until the end of bleeding or up to 2 minutes time</time_frame>
    <description>The amount of capillary blood volume collected after a single lancing of the fingertip.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain perception</measure>
    <time_frame>directly after lancing</time_frame>
    <description>The intensity of pain perceived by the patient was assessed with the use of the numeric Visual Analog Scale (VAS). The Subject marked on the scale the number from 0 (&quot;no pain&quot;) to 10 (&quot;worst imaginable pain&quot;) that represented their perception of pain. A higher score indicated greater pain intensity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain perception</measure>
    <time_frame>after 30 minutes ± 5 min after lancing</time_frame>
    <description>The intensity of pain perceived by the patient was assessed with the use of the numeric Visual Analog Scale (VAS). The Subject marked on the scale the number from 0 (&quot;no pain&quot;) to 10 (&quot;worst imaginable pain&quot;) that represented their perception of pain. A higher score indicated greater pain intensity.</description>
  </secondary_outcome>
  <number_of_arms>16</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 610</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 553-556</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 430</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 420</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 520</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 450</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 545-549</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Owem Mumford lancet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Medicore lancet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arkray lancet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Medipurpose lancet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sterilance lancet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dynarex lancet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ypsomed lancet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Promismed lancet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cambridge Sensors lancet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acti-Lance Lite</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 610</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 610</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acti-Lance Universal</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 610</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 610</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acti-Lance Special</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 610</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 610</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medlance Plus Super Lite</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 553-556</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 553</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medlance Plus Lite</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 553-556</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 553</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medlance Plus Universal</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 553-556</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 554</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medlance Plus Extra</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 553-556</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 555</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medlance Plus Special</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 553-556</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 556</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prolance Micro Flow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 430</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 430</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prolance Low Flow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 430</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 430</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prolance Normal Flow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 430</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 430</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prolance High Flow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 430</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 430</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prolance Max Flow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 430</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 430</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prolance Pediatric</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 430</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 430</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Haemolance Micro Flow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 420</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 420</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Haemolance Low Flow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 420</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 420</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Haemolnace Normal Flow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 420</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 420</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Haemolance High Flow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 420</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 420</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Haemolance Max Flow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 420</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 420</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Haemolance Pediatric</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 420</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 420</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MediSafe Solo 29 Gauge</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 520</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 520</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MediSafe Solo 23 Gauge</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 520</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 520</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ergoLance Micro Flow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 450</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 450</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ergoLance Normal Flow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 450</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 450</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ergoLance High Flow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 450</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 450</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medlance (light blue)</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 545-549</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 545</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medlance (blue)</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 545-549</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 545</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medlance (dark blue)</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 545-549</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 546</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medlance (yellow)</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 545-549</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 547</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medlance (orange)</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 545-549</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 548</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medlance (red)</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>HTL-STREFA S.A.safety lancet type 545-549</arm_group_label>
    <other_name>HTL-STREFA S.A. safety lancet type 549</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Unistik 3 Extra</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Owem Mumford lancet</arm_group_label>
    <other_name>Owem Mumford lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Unistik 3 Comfort</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Owem Mumford lancet</arm_group_label>
    <other_name>Owem Mumford lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Unistik Touch</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Owem Mumford lancet</arm_group_label>
    <other_name>Owem Mumford lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ReadyLance (blue)</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Medicore lancet</arm_group_label>
    <other_name>Medicore lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ReadyLance (orange)</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Medicore lancet</arm_group_label>
    <other_name>Medicore lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AssureLance</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Arkray lancet</arm_group_label>
    <other_name>Arkray lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AssureLance MicroFlow</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Arkray lancet</arm_group_label>
    <other_name>Arkray lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surgilance</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Medipurpose lancet</arm_group_label>
    <other_name>Medipurpose lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surgilance Lite (grey)</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Medipurpose lancet</arm_group_label>
    <other_name>Medipurpose lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Surgilance Lite (purple)</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Medipurpose lancet</arm_group_label>
    <other_name>Medipurpose lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SteriLance Lite2</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Sterilance lancet</arm_group_label>
    <other_name>Sterilance lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SensiLance (pink)</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Dynarex lancet</arm_group_label>
    <other_name>Dynarex lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SteriLance Press</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Sterilance lancet</arm_group_label>
    <other_name>Sterilance lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SensiLance (orange)</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Dynarex lancet</arm_group_label>
    <other_name>Dynarex lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mylife</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Ypsomed lancet</arm_group_label>
    <other_name>Ypsomed lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VeriFine</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Promismed lancet</arm_group_label>
    <other_name>Promismed lancet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Microdot</intervention_name>
    <description>Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.&#xD;
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.</description>
    <arm_group_label>Cambridge Sensors lancet</arm_group_label>
    <other_name>Cambridge Sensors lancet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing to sign the informed consent.&#xD;
&#xD;
          -  Male and female volunteers&#xD;
&#xD;
          -  Age between 18 and 65 inclusive&#xD;
&#xD;
          -  Able to communicate well with the Investigator and comply with the requirements of the&#xD;
             study&#xD;
&#xD;
          -  Volunteers who are in good physical and mental health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Confirmed or suspected malignant cancer&#xD;
&#xD;
          -  Pregnancy or breastfeeding (only for women with childbearing potential based on&#xD;
             pregnancy test conducted at Site)&#xD;
&#xD;
          -  History of poor blood circulation.&#xD;
&#xD;
          -  Any skin condition on his or her fingers that prevents blood sampling&#xD;
&#xD;
          -  Anxiety with needles or finger pricks&#xD;
&#xD;
          -  Clotting disorders (including bleeding) in medical history&#xD;
&#xD;
          -  Neuropathy or other condition affecting sensation in the hands.&#xD;
&#xD;
          -  History of blood borne infection (e.g., HIV, hepatitis B or C, syphilis, malaria,&#xD;
             babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T&#xD;
             lymphotropic virus Type 1, Creutzfeldt-Jakob disease)&#xD;
&#xD;
          -  Currently participating in another study&#xD;
&#xD;
          -  History of drug or alcohol abuse within the 12 months prior to screening or evidence&#xD;
             of such abuse&#xD;
&#xD;
          -  Intake of alcohol within 48 hours prior to the start of the study (self-reporting)&#xD;
&#xD;
          -  Donation or loss of 400 mL or more of blood within 4 weeks prior to the start of the&#xD;
             study&#xD;
&#xD;
          -  Any other condition that in the Investigator opinion may negatively influence&#xD;
             Subject's participation in the study&#xD;
&#xD;
          -  Intake of medicines that affect blood coagulability (including anticoagulants such as&#xD;
             vitamin K, antivirals and anticoagulants such as heparin, aspirin, thrombin&#xD;
             inhibitors, vitamin K antagonists).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>BioResearch Group Sp. z o.o.</name>
      <address>
        <city>Nadarzyn</city>
        <state>Mazowieckie</state>
        <zip>05-830</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 22, 2018</last_update_submitted>
  <last_update_submitted_qc>November 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>safety lancets</keyword>
  <keyword>lancet</keyword>
  <keyword>capillary blood</keyword>
  <keyword>capillary blood sampling</keyword>
  <keyword>blood volume</keyword>
  <keyword>pain</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diazepam</mesh_term>
  </intervention_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/NCT03752229
org study id: 02LAN2017
nct id: NCT03752229
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study was a randomized, single blind, uni-center pivotal study in male and female healthy
      volunteers, to determine capillary blood volume and pain perception obtained in a process of
      puncturing with different safety lancets.

      A group of three hundred (300) Caucasian male and female Subjects was randomized (aged > 18
      to < 65 years old) who were in good physical and mental condition. The Subjects had 4 (four)
      fingers (two fingers from each hand) lanced each with a different type of safety lancet.
      Overall, 4 (four) different safety lancets were investigated per each Subject.

      Overall, 48 (forty eight) different safety lancets (4 different safety lancets per one
      Subject) were investigated, the capillary blood volume and pain were measured.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Volume (microliters) of blood in the capillary tube
time frame: The blood volume was noted after 20 seconds
description: The amount of capillary blood volume collected after a single lancing of the fingertip.
measure: Volume (microliters) of blood in the capillary tube
time frame: The blood volume was noted until the end of bleeding or up to 2 minutes time
description: The amount of capillary blood volume collected after a single lancing of the fingertip.
measure: Pain perception
time frame: directly after lancing
description: The intensity of pain perceived by the patient was assessed with the use of the numeric Visual Analog Scale (VAS). The Subject marked on the scale the number from 0 ("no pain") to 10 ("worst imaginable pain") that represented their perception of pain. A higher score indicated greater pain intensity.
measure: Pain perception
time frame: after 30 minutes ± 5 min after lancing
description: The intensity of pain perceived by the patient was assessed with the use of the numeric Visual Analog Scale (VAS). The Subject marked on the scale the number from 0 ("no pain") to 10 ("worst imaginable pain") that represented their perception of pain. A higher score indicated greater pain intensity.
arm group label: HTL-STREFA S.A.safety lancet type 610
arm group type: Experimental
arm group label: HTL-STREFA S.A.safety lancet type 553-556
arm group type: Experimental
arm group label: HTL-STREFA S.A.safety lancet type 430
arm group type: Experimental
arm group label: HTL-STREFA S.A.safety lancet type 420
arm group type: Experimental
arm group label: HTL-STREFA S.A.safety lancet type 520
arm group type: Experimental
arm group label: HTL-STREFA S.A.safety lancet type 450
arm group type: Experimental
arm group label: HTL-STREFA S.A.safety lancet type 545-549
arm group type: Experimental
arm group label: Owem Mumford lancet
arm group type: Experimental
arm group label: Medicore lancet
arm group type: Experimental
arm group label: Arkray lancet
arm group type: Experimental
arm group label: Medipurpose lancet
arm group type: Experimental
arm group label: Sterilance lancet
arm group type: Experimental
arm group label: Dynarex lancet
arm group type: Experimental
arm group label: Ypsomed lancet
arm group type: Experimental
arm group label: Promismed lancet
arm group type: Experimental
arm group label: Cambridge Sensors lancet
arm group type: Experimental
intervention type: Device
intervention name: Acti-Lance Lite
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 610
other name: HTL-STREFA S.A. safety lancet type 610
intervention type: Device
intervention name: Acti-Lance Universal
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 610
other name: HTL-STREFA S.A. safety lancet type 610
intervention type: Device
intervention name: Acti-Lance Special
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 610
other name: HTL-STREFA S.A. safety lancet type 610
intervention type: Device
intervention name: Medlance Plus Super Lite
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 553-556
other name: HTL-STREFA S.A. safety lancet type 553
intervention type: Device
intervention name: Medlance Plus Lite
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 553-556
other name: HTL-STREFA S.A. safety lancet type 553
intervention type: Device
intervention name: Medlance Plus Universal
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 553-556
other name: HTL-STREFA S.A. safety lancet type 554
intervention type: Device
intervention name: Medlance Plus Extra
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 553-556
other name: HTL-STREFA S.A. safety lancet type 555
intervention type: Device
intervention name: Medlance Plus Special
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 553-556
other name: HTL-STREFA S.A. safety lancet type 556
intervention type: Device
intervention name: Prolance Micro Flow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 430
other name: HTL-STREFA S.A. safety lancet type 430
intervention type: Device
intervention name: Prolance Low Flow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 430
other name: HTL-STREFA S.A. safety lancet type 430
intervention type: Device
intervention name: Prolance Normal Flow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 430
other name: HTL-STREFA S.A. safety lancet type 430
intervention type: Device
intervention name: Prolance High Flow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 430
other name: HTL-STREFA S.A. safety lancet type 430
intervention type: Device
intervention name: Prolance Max Flow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 430
other name: HTL-STREFA S.A. safety lancet type 430
intervention type: Device
intervention name: Prolance Pediatric
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 430
other name: HTL-STREFA S.A. safety lancet type 430
intervention type: Device
intervention name: Haemolance Micro Flow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 420
other name: HTL-STREFA S.A. safety lancet type 420
intervention type: Device
intervention name: Haemolance Low Flow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 420
other name: HTL-STREFA S.A. safety lancet type 420
intervention type: Device
intervention name: Haemolnace Normal Flow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 420
other name: HTL-STREFA S.A. safety lancet type 420
intervention type: Device
intervention name: Haemolance High Flow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 420
other name: HTL-STREFA S.A. safety lancet type 420
intervention type: Device
intervention name: Haemolance Max Flow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 420
other name: HTL-STREFA S.A. safety lancet type 420
intervention type: Device
intervention name: Haemolance Pediatric
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 420
other name: HTL-STREFA S.A. safety lancet type 420
intervention type: Device
intervention name: MediSafe Solo 29 Gauge
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 520
other name: HTL-STREFA S.A. safety lancet type 520
intervention type: Device
intervention name: MediSafe Solo 23 Gauge
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 520
other name: HTL-STREFA S.A. safety lancet type 520
intervention type: Device
intervention name: ergoLance Micro Flow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 450
other name: HTL-STREFA S.A. safety lancet type 450
intervention type: Device
intervention name: ergoLance Normal Flow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 450
other name: HTL-STREFA S.A. safety lancet type 450
intervention type: Device
intervention name: ergoLance High Flow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 450
other name: HTL-STREFA S.A. safety lancet type 450
intervention type: Device
intervention name: Medlance (light blue)
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 545-549
other name: HTL-STREFA S.A. safety lancet type 545
intervention type: Device
intervention name: Medlance (blue)
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 545-549
other name: HTL-STREFA S.A. safety lancet type 545
intervention type: Device
intervention name: Medlance (dark blue)
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 545-549
other name: HTL-STREFA S.A. safety lancet type 546
intervention type: Device
intervention name: Medlance (yellow)
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 545-549
other name: HTL-STREFA S.A. safety lancet type 547
intervention type: Device
intervention name: Medlance (orange)
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 545-549
other name: HTL-STREFA S.A. safety lancet type 548
intervention type: Device
intervention name: Medlance (red)
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: HTL-STREFA S.A.safety lancet type 545-549
other name: HTL-STREFA S.A. safety lancet type 549
intervention type: Device
intervention name: Unistik 3 Extra
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Owem Mumford lancet
other name: Owem Mumford lancet
intervention type: Device
intervention name: Unistik 3 Comfort
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Owem Mumford lancet
other name: Owem Mumford lancet
intervention type: Device
intervention name: Unistik Touch
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Owem Mumford lancet
other name: Owem Mumford lancet
intervention type: Device
intervention name: ReadyLance (blue)
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Medicore lancet
other name: Medicore lancet
intervention type: Device
intervention name: ReadyLance (orange)
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Medicore lancet
other name: Medicore lancet
intervention type: Device
intervention name: AssureLance
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Arkray lancet
other name: Arkray lancet
intervention type: Device
intervention name: AssureLance MicroFlow
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Arkray lancet
other name: Arkray lancet
intervention type: Device
intervention name: Surgilance
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Medipurpose lancet
other name: Medipurpose lancet
intervention type: Device
intervention name: Surgilance Lite (grey)
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Medipurpose lancet
other name: Medipurpose lancet
intervention type: Device
intervention name: Surgilance Lite (purple)
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Medipurpose lancet
other name: Medipurpose lancet
intervention type: Device
intervention name: SteriLance Lite2
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Sterilance lancet
other name: Sterilance lancet
intervention type: Device
intervention name: SensiLance (pink)
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Dynarex lancet
other name: Dynarex lancet
intervention type: Device
intervention name: SteriLance Press
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Sterilance lancet
other name: Sterilance lancet
intervention type: Device
intervention name: SensiLance (orange)
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Dynarex lancet
other name: Dynarex lancet
intervention type: Device
intervention name: mylife
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Ypsomed lancet
other name: Ypsomed lancet
intervention type: Device
intervention name: VeriFine
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Promismed lancet
other name: Promismed lancet
intervention type: Device
intervention name: Microdot
description: Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler.
arm group label: Cambridge Sensors lancet
other name: Cambridge Sensors lancet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Diazepam