<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/NCT02265380</url>
  </required_header>
  <id_info>
    <org_study_id>OMT-CT-002-PED</org_study_id>
    <nct_id>NCT02265380</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population</brief_title>
  <official_title>A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Optomeditech Oy</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital District of Helsinki and Uusimaa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CardioMed Device Consultants, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Optomeditech Oy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, single-center, open-label, randomized controlled trial to demonstrate the&#xD;
      safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study&#xD;
      hypothesis is that OptiVein IV Catheter use will be superior to the control in successful&#xD;
      venous access after first attempt.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The OptiVein System uses transillumination of skin tissue to aid in cannulation and consists&#xD;
      of the OptiVein IV Catheter with an integrated optical fiber, and an electronic unit. The&#xD;
      electronic unit is a portable internally powered generator of low power visible laser light&#xD;
      of green color. The electronic unit generates visible light, which is released from the tip&#xD;
      of the needle into the soft tissue around the tip of the IV catheter. Light is visible&#xD;
      through the skin and helps mark the location of the tip of the needle under the skin and&#xD;
      against the vein.&#xD;
&#xD;
      In addition to pinpointing the exact location of the tip of the needle, the OptiVein System&#xD;
      informs the user of the exact moment of penetration of the tip of the needle into the blood&#xD;
      vessel. Hemoglobin in blood strongly absorbs visible light of specific wavelengths, so when&#xD;
      the needle enters the blood vessel, the light is instantly absorbed by blood, which causes&#xD;
      instant fading of skin transillumination. Instant disappearance of tissue illumination&#xD;
      indicates successful venipuncture. The user can then lower the angle of the needle and start&#xD;
      to advance the cannula over the needle into the blood vessel. Such optical confirmation is&#xD;
      much faster than the traditional observation of blood in the flashback chamber of the needle&#xD;
      and should lead to increased first-attempt success rates and decreased cannulation-related&#xD;
      complications.&#xD;
&#xD;
      The use of OptiVein device will be compared to the use of a traditional IV catheter to&#xD;
      explore the potential increase of effectiveness of cannulation with OptiVein versus&#xD;
      traditional IV catheters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inability to recruit patients sufficiently&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 25, 2016</completion_date>
  <primary_completion_date type="Actual">August 25, 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful IV insertion on the first attempt</measure>
    <time_frame>Immediate</time_frame>
    <description>Successful IV insertion on the first attempt, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total number of attempts required for successful IV insertion</measure>
    <time_frame>Immediate</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to successful IV insertion</measure>
    <time_frame>Immediate</time_frame>
    <description>Defined as time from the first skin puncture to placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of blood extravasation resulting in a hematoma</measure>
    <time_frame>Up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of fluid extravasation delivered through catheter</measure>
    <time_frame>Up to 72 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of infection (phlebitis, dermatitis and induration)</measure>
    <time_frame>Up to 72 hours</time_frame>
    <description>Incidence of infection (phlebitis, dermatitis and induration) at insertion site through 72 hours or at the time of catheter removal, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unplanned withdrawal of IV catheter</measure>
    <time_frame>Up to 72 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">188</enrollment>
  <condition>Peripheral Venous Catheterization</condition>
  <arm_group>
    <arm_group_label>Treatment with OptiVein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient will have an IV catheter placed with the use of OptiVein device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment with Vasofix Certo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient will have an IV catheter placed with the use of Vasofix Certo device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placement of IV catheter</intervention_name>
    <arm_group_label>Treatment with OptiVein</arm_group_label>
    <arm_group_label>Treatment with Vasofix Certo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged newborn to 12 years&#xD;
&#xD;
          -  Has written or verbal order for insertion of an IV&#xD;
&#xD;
          -  Requires peripheral IV therapy (catheter)&#xD;
&#xD;
          -  Has an insertion site in the hand, forearm, foot, leg, or head free of deformities,&#xD;
             phlebitis, infiltration, dermatitis, burns, lesions or tattoos&#xD;
&#xD;
          -  Demonstrates cooperation with a catheter insertion and the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In the newborn nursery or intensive care units (neonatal or pediatric)&#xD;
&#xD;
          -  On patient-controlled analgesia pump&#xD;
&#xD;
          -  Patient is anesthetized&#xD;
&#xD;
          -  Terminally ill&#xD;
&#xD;
          -  Transferred from the operating room less than 8 hours postanasthesia&#xD;
&#xD;
          -  Any child the research staff deem unobservable&#xD;
&#xD;
          -  The study IV catheter site will be placed below an old infusion site&#xD;
&#xD;
          -  The study IV site needs to be immobilized with a splint or other devices&#xD;
&#xD;
          -  Has or has had a previous IV catheter related phlebitis or infiltration during current&#xD;
             hospitalization&#xD;
&#xD;
          -  Will require a power injection for a radiologic procedure during participation in this&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomi Taivainen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital District of Helsinki and Uusimaa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helsinki and Uusimaa Hospital District, Children's Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>February 28, 2017</last_update_submitted>
  <last_update_submitted_qc>February 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2017</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/NCT02265380
org study id: OMT-CT-002-PED
nct id: NCT02265380
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
A prospective, single-center, open-label, randomized controlled trial to demonstrate the
      safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study
      hypothesis is that OptiVein IV Catheter use will be superior to the control in successful
      venous access after first attempt.
The OptiVein System uses transillumination of skin tissue to aid in cannulation and consists
      of the OptiVein IV Catheter with an integrated optical fiber, and an electronic unit. The
      electronic unit is a portable internally powered generator of low power visible laser light
      of green color. The electronic unit generates visible light, which is released from the tip
      of the needle into the soft tissue around the tip of the IV catheter. Light is visible
      through the skin and helps mark the location of the tip of the needle under the skin and
      against the vein.

      In addition to pinpointing the exact location of the tip of the needle, the OptiVein System
      informs the user of the exact moment of penetration of the tip of the needle into the blood
      vessel. Hemoglobin in blood strongly absorbs visible light of specific wavelengths, so when
      the needle enters the blood vessel, the light is instantly absorbed by blood, which causes
      instant fading of skin transillumination. Instant disappearance of tissue illumination
      indicates successful venipuncture. The user can then lower the angle of the needle and start
      to advance the cannula over the needle into the blood vessel. Such optical confirmation is
      much faster than the traditional observation of blood in the flashback chamber of the needle
      and should lead to increased first-attempt success rates and decreased cannulation-related
      complications.

      The use of OptiVein device will be compared to the use of a traditional IV catheter to
      explore the potential increase of effectiveness of cannulation with OptiVein versus
      traditional IV catheters.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful IV insertion on the first attempt
time frame: Immediate
description: Successful IV insertion on the first attempt, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.
measure: Total number of attempts required for successful IV insertion
time frame: Immediate
measure: Time to successful IV insertion
time frame: Immediate
description: Defined as time from the first skin puncture to placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.
measure: Incidence of blood extravasation resulting in a hematoma
time frame: Up to 72 hours
measure: Incidence of fluid extravasation delivered through catheter
time frame: Up to 72 hours
measure: Incidence of infection (phlebitis, dermatitis and induration)
time frame: Up to 72 hours
description: Incidence of infection (phlebitis, dermatitis and induration) at insertion site through 72 hours or at the time of catheter removal, whichever occurs first.
measure: Unplanned withdrawal of IV catheter
time frame: Up to 72 hours
arm group label: Treatment with OptiVein
arm group type: Experimental
description: The patient will have an IV catheter placed with the use of OptiVein device.
arm group label: Treatment with Vasofix Certo
arm group type: Active Comparator
description: The patient will have an IV catheter placed with the use of Vasofix Certo device.
intervention type: Device
intervention name: Placement of IV catheter
arm group label: Treatment with OptiVein
arm group label: Treatment with Vasofix Certo
criteria: 
gender: All
minimum age: N/A
maximum age: 12 Years
healthy volunteers: No
last name: Tomi Taivainen, MD, PhD
role: Principal Investigator
affiliation: Hospital District of Helsinki and Uusimaa
facility: 
country: Finland
responsible party type: Sponsor