<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/NCT03752632</url>
  </required_header>
  <id_info>
    <org_study_id>PHY0011</org_study_id>
    <nct_id>NCT03752632</nct_id>
  </id_info>
  <brief_title>Veinplicity for Improved Venous Access: The VIVA Trial</brief_title>
  <official_title>Veinplicity for Improved Venous Access: The VIVA Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Physeon GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regulatory Clinical Research Institute (RCRI)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Physeon GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the safety and effectiveness of the Veinplicity device to improve the&#xD;
      visualization and palpability of difficult-to-access veins for intravenous cannulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized controlled study that will assess ability of Veinplicity to&#xD;
      improve successful peripheral vein cannulation at the first stick in enrolled subjects.&#xD;
      Potential subjects will undergo a peripheral vein assessment by a study clinician, which is&#xD;
      standard of care prior to peripheral vein cannulation (PVC) for the establishment of&#xD;
      intravenous (IV) access. Adults who are assessed as having &quot;fair or poor&quot; vein quality will&#xD;
      be consented, enrolled and randomized into the study. Subjects will be randomized in a 1:1&#xD;
      ratio to either (1) tourniquet alone (control group); or (2) Veinplicity with tourniquet&#xD;
      (treatment group). The primary endpoint is first-stick success. Clinicians will use an 18-,&#xD;
      20- or 22-gauge cannula. Clinician and subject satisfaction will be separately assessed using&#xD;
      surveys on Day 0. Subjects in both groups will be followed for one day (either phone or&#xD;
      in-hospital visit) after enrollment for safety. Qualified study clinicians must have at least&#xD;
      one year of experience inserting peripheral IVs and must perform an average of five PVCs per&#xD;
      week. The primary hypothesis to be tested is: Veinplicity with tourniquet is superior to&#xD;
      tourniquet alone for successful peripheral vein access at first stick when used to cannulate&#xD;
      subjects assessed as having a fair or poor level of vein quality. It is expected that this&#xD;
      study will enroll approximately 246 subjects; 123 per study group. It is expected that up to&#xD;
      five sites will be involved in this study. A planned interim analysis will be conducted to&#xD;
      reassess the study planned sample size when approximately 50% of subjects have been enrolled.&#xD;
      Enrollment will not stop during the interim analysis activities. Safety will be evaluated by&#xD;
      the collection and analysis of the incidence and severity of all procedure- and/or&#xD;
      device-related adverse events through the Day 1 phone call/visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business reasons not related to safety or trial conduct&#xD;
  </why_stopped>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">July 22, 2019</completion_date>
  <primary_completion_date type="Actual">July 22, 2019</primary_completion_date>
  <phase>Phase 3</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>First-stick success when accessing a peripheral vein for cannulation</measure>
    <time_frame>Day 0</time_frame>
    <description>successful peripheral vein access for the first-stick with use of Veinplicity with tourniquet versus tourniquet alone</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Device and/or procedure-related adverse events</measure>
    <time_frame>Day 1</time_frame>
    <description>Safety will be evaluated by the collection and analysis of the incidence and severity of all procedure- and/or device-related adverse events through the Day 1 post-insertion phone call/visit.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Number of attempted sticks to successful vein access</measure>
    <time_frame>Day 0</time_frame>
    <description>Number of attempted sticks to successful vein access</description>
  </other_outcome>
  <other_outcome>
    <measure>Total procedure time</measure>
    <time_frame>Day 0</time_frame>
    <description>For control subjects, timing begins at the start of skin preparation or tourniquet application on the first arm (whichever is first per standard of practice) to either obtaining successful vein access or until the fourth attempt at cannulation fails. For Veinplicity subjects, timing begins at the start of electrode application on the first arm to either obtaining successful vein access or until the fourth attempt at cannulation fails.</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to first-stick success</measure>
    <time_frame>Day 0</time_frame>
    <description>time from tourniquet application for the initial cannulation attempt to declaration of first-stick success/failure.</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for control subject's: Past IV starts have been difficult, uncomfortable or painful.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Control subject's assessment of pain associated with past IV starts:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
Strongly Agree&#xD;
Agree&#xD;
Neutral&#xD;
Disagree&#xD;
Strongly Disagree Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for control subject's: Today, my IV was started easily.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Control subject's assessment of how easy they believe today's IV start was:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
Strongly Agree&#xD;
Agree&#xD;
Neutral&#xD;
Disagree&#xD;
Strongly Disagree Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for control subject's: Pain associated with IV start procedure today.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Control subject's assessment of pain level associated with today's IV start procedure:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
Not painful at all&#xD;
Almost no pain&#xD;
Some pain&#xD;
Moderate pain&#xD;
Extreme pain Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for control subject's: Pain associated with today's IV start compared to past IV starts.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Control subject's assessment of pain associated with today's IV start compared to past IV starts:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
Much less pain&#xD;
Less Painful&#xD;
Equal Pain&#xD;
More Painful&#xD;
Much More Painful Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for control subject's: Anxiety associated with the IV start procedure today.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Control subject's assessment of anxiety level associated with today's IV start procedure:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
Not Anxious&#xD;
Slightly Anxious&#xD;
Anxious&#xD;
Moderately Anxious&#xD;
Very Anxious Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for control subject's: Anxiety associated with today's IV start compared to past IV starts.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Control subject's assessment of anxiety level associated with today's IV start procedure compared to past IV starts:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
A Lot Less Anxious&#xD;
Less Anxious&#xD;
The Same&#xD;
More Anxious&#xD;
Very Anxious Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for control subject's: Overall, I was satisfied with today's IV start.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Control subject's overall assessment of satisfaction with today's IV start:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
Strongly Agree&#xD;
Agree&#xD;
Neutral&#xD;
Disagree&#xD;
Strongly Disagree Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for treatment subject's: Past IV starts have been difficult, uncomfortable or painful.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Veinplicity subject's assessment of pain associated with past IV starts:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
Strongly Agree&#xD;
Agree&#xD;
Neutral&#xD;
Disagree&#xD;
Strongly Disagree Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for treatment subject's: Today, my IV was started easily.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Veinplicity subject's assessment of how easy they believe today's IV start was:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
Strongly Agree&#xD;
Agree&#xD;
Neutral&#xD;
Disagree&#xD;
Strongly Disagree Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for treatment subject's: Pain associated with IV start procedure today.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Veinplicity subject's assessment of pain level associated with today's IV start procedure:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
Not painful at all&#xD;
Almost no pain&#xD;
Some pain&#xD;
Moderate pain&#xD;
Extreme pain Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for treatment subject's: Pain associated with today's IV start compared to past IV starts.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Veinplicity subject's assessment of pain level associated with today's IV start compared to past IV starts:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
Not painful at all&#xD;
Almost no pain&#xD;
Some pain&#xD;
Moderate pain&#xD;
Extreme pain Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for treatment subject's: Anxiety associated with the IV start procedure today.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Veinplicity subject's assessment of anxiety level associated with today's IV start procedure:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
Not Anxious&#xD;
Slightly Anxious&#xD;
Anxious&#xD;
Moderately Anxious&#xD;
Very Anxious Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for treatment subject's: Anxiety associated with today's IV start compared to past IV starts.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Veinplicity subject's assessment of anxiety level associated with today's IV start procedure compared to past IV starts:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
A Lot Less Anxious&#xD;
Less Anxious&#xD;
The Same&#xD;
More Anxious&#xD;
Very Anxious Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for treatment subject's: Pain associated with the Veinplicity stimulation.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Veinplicity subject's assessment on level of pain associated with today's Veinplicity stimulation:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
Not painful at all&#xD;
Almost no pain&#xD;
Some pain&#xD;
Moderate pain&#xD;
Extreme pain Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for treatment subject's: Veinplicity improved the overall success of my experience.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Veinplicity subject's assessment on how Veinplicity improved overall success of their experience today:&#xD;
Strongly Agree&#xD;
Agree&#xD;
Neutral&#xD;
Disagree&#xD;
Strongly Disagree Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for treatment subject's: The Veinplicity device made it easier for the nurse to find a vein for my IV start today.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Veinplicity subject's assessment of Veinplicity device made it easier for nurse to find a vein for today's IV start:&#xD;
Strongly Agree&#xD;
Agree&#xD;
Neutral&#xD;
Disagree&#xD;
Strongly Disagree Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for treatment subject's: I would choose the Veinplicity again for future IV starts.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Veinplicity subject's likelihood of choosing to use the Veinplicity device for future IV starts:&#xD;
Definitely Agree&#xD;
Agree&#xD;
Neutral&#xD;
Disagree&#xD;
Definitely Disagree Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject Satisfaction Survey question for treatment subject's: Overall, I was satisfied with today's IV start.</measure>
    <time_frame>Day 0 after completion of the study procedure</time_frame>
    <description>Veinplicity subject's overall assessment of satisfaction with today's IV start:&#xD;
Scale 1 - 5; Unable to Evaluate&#xD;
Strongly Agree&#xD;
Agree&#xD;
Neutral&#xD;
Disagree&#xD;
Strongly Disagree Unable to Evaluate</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinician satisfaction</measure>
    <time_frame>Assessed on Day 0 after completion of the study procedure</time_frame>
    <description>On Day 0 after each Veinplicity subject's IV procedure, each clinician will complete a Clinician Satisfaction Survey, after cannulation has been attempted and subject is declared either a study success or failure. Clinician's are not to complete this survey for control subjects.&#xD;
Scale 1 to 5:&#xD;
= Strongly Agree&#xD;
= Moderately Agree&#xD;
= Neutral&#xD;
= Moderately Disagree&#xD;
= Strongly Disagree QUESTION 1: Veinplicity was easy to use. QUESTION 2: Veinplicity improved vein palpability. QUESTION 3: Veinplicity improved vein visualization. QUESTION 4: Veinplicity made it easier to identify a suitable vessel to access.&#xD;
QUESTION 5: Veinplicity improved the overall success of the experience. QUESTION 6: Veinplicity resulted in a more positive and less anxious experience for the patient.&#xD;
QUESTION 7: I would recommend Veinplicity to a colleague or patient. QUESTION 8: Overall, I was satisfied with using the Veinplicity device.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the vein quality score from baseline to pre-cannulation tourniquet application</measure>
    <time_frame>Day 0</time_frame>
    <description>scores at baseline and post-stimulation to be assessed at time of tourniquet application by the same clinician.&#xD;
Scale = Vessel Health and Preservation (VHP) Peripheral Vein Assessment Scale. Grade 1 = Vein Quality Excellent (4-5 palpable/easily visible veins suitable to cannulate) Grade 2 = Vein Quality Good (2-3 palpable/visible veins suitable to cannulate Grade 3 = Vein Quality Fair (1-2 palpable/visible veins suitable to cannulate [veins may be small, scarred or difficult to find and require heat packs to aid vasodilation]) Grade 4 = Vein Quality Poor (veins not palpable/visible [requires ultrasound assistance or infrared viewer]) Grade 5 = Vein Quality None identifiable (no visible [naked eye or aids] or palpable veins) Fair or Poor indicates to clinician that cannulation may be challenging and require extra time or resources; use of Veinplicity may increase vessel size and improve identification of vessels suitable for cannulation</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Difficult-to-access Veins for Intravenous Cannulation</condition>
  <arm_group>
    <arm_group_label>Veinplicity with tourniquet (treatment)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Veinplicity with tourniquet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tourniquet (control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control: Tourniquet</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Veinplicity with tourniquet</intervention_name>
    <description>Veinplicity will be used with a tourniquet</description>
    <arm_group_label>Veinplicity with tourniquet (treatment)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tourniquet</intervention_name>
    <description>A tourniquet alone will be used.</description>
    <arm_group_label>Tourniquet (control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is ≥ 22 years old.&#xD;
&#xD;
          -  Subject is assessed as having fair or poor vein quality.&#xD;
&#xD;
          -  Subject's both arms are suitable for cannulation.&#xD;
&#xD;
          -  Subject will not suffer harm from a delay in having an IV established as determined by&#xD;
             the treating clinician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has existing intravenous access.&#xD;
&#xD;
          -  Subject has a planned or existing intra-arterial access.&#xD;
&#xD;
          -  Subject has broken, infected or irritated skin and/or dermatological conditions, e.g.,&#xD;
             eczema, psoriasis and/or allergic reactions, on either forearm.&#xD;
&#xD;
          -  Subject has an active implantable medical device.&#xD;
&#xD;
          -  Subject wears a transdermal drug delivery patch on her/his forearm.&#xD;
&#xD;
          -  Subject has an active/suspected deep vein thrombosis or thrombophlebitis, impaired&#xD;
             circulation, impaired sensation, active/uncontrolled bleeding, recently radiated&#xD;
             tissue, recent fracture, recent injury or surgery resulting in blood loss &gt; 100 mL,&#xD;
             osteoporosis, localized abscess, localized tuberculosis, and/or a chronic wound with&#xD;
             potential underlying osteomyelitis.&#xD;
&#xD;
          -  Subject has impaired cognition or communication (unable to provide accurate feedback).&#xD;
&#xD;
          -  Subject has a history of seizures and/or epilepsy, and/or a recent seizure, possible&#xD;
             recent seizure or a history of possible seizures.&#xD;
&#xD;
          -  Subject is pregnant and/or breastfeeding at the time of study enrollment.&#xD;
&#xD;
          -  Subject has, at the site of or in between Veinplicity electrode application sites, an&#xD;
             active/suspected malignancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory J Schears, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Midwest Immunology Clinic and Infusion Center</name>
      <address>
        <city>Plymouth</city>
        <state>Minnesota</state>
        <zip>55446</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic-Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regions Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>October 28, 2019</last_update_submitted>
  <last_update_submitted_qc>October 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intravenous</keyword>
  <keyword>peripheral vein</keyword>
  <keyword>cannulation</keyword>
  <keyword>IV access</keyword>
  <!-- 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/NCT03752632
org study id: PHY0011
nct id: NCT03752632
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study will assess the safety and effectiveness of the Veinplicity device to improve the
      visualization and palpability of difficult-to-access veins for intravenous cannulation.
This is a prospective, randomized controlled study that will assess ability of Veinplicity to
      improve successful peripheral vein cannulation at the first stick in enrolled subjects.
      Potential subjects will undergo a peripheral vein assessment by a study clinician, which is
      standard of care prior to peripheral vein cannulation (PVC) for the establishment of
      intravenous (IV) access. Adults who are assessed as having "fair or poor" vein quality will
      be consented, enrolled and randomized into the study. Subjects will be randomized in a 1:1
      ratio to either (1) tourniquet alone (control group); or (2) Veinplicity with tourniquet
      (treatment group). The primary endpoint is first-stick success. Clinicians will use an 18-,
      20- or 22-gauge cannula. Clinician and subject satisfaction will be separately assessed using
      surveys on Day 0. Subjects in both groups will be followed for one day (either phone or
      in-hospital visit) after enrollment for safety. Qualified study clinicians must have at least
      one year of experience inserting peripheral IVs and must perform an average of five PVCs per
      week. The primary hypothesis to be tested is: Veinplicity with tourniquet is superior to
      tourniquet alone for successful peripheral vein access at first stick when used to cannulate
      subjects assessed as having a fair or poor level of vein quality. It is expected that this
      study will enroll approximately 246 subjects; 123 per study group. It is expected that up to
      five sites will be involved in this study. A planned interim analysis will be conducted to
      reassess the study planned sample size when approximately 50% of subjects have been enrolled.
      Enrollment will not stop during the interim analysis activities. Safety will be evaluated by
      the collection and analysis of the incidence and severity of all procedure- and/or
      device-related adverse events through the Day 1 phone call/visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: First-stick success when accessing a peripheral vein for cannulation
time frame: Day 0
description: successful peripheral vein access for the first-stick with use of Veinplicity with tourniquet versus tourniquet alone
measure: Device and/or procedure-related adverse events
time frame: Day 1
description: Safety will be evaluated by the collection and analysis of the incidence and severity of all procedure- and/or device-related adverse events through the Day 1 post-insertion phone call/visit.
measure: Number of attempted sticks to successful vein access
time frame: Day 0
description: Number of attempted sticks to successful vein access
measure: Total procedure time
time frame: Day 0
description: For control subjects, timing begins at the start of skin preparation or tourniquet application on the first arm (whichever is first per standard of practice) to either obtaining successful vein access or until the fourth attempt at cannulation fails. For Veinplicity subjects, timing begins at the start of electrode application on the first arm to either obtaining successful vein access or until the fourth attempt at cannulation fails.
measure: Time to first-stick success
time frame: Day 0
description: time from tourniquet application for the initial cannulation attempt to declaration of first-stick success/failure.
measure: Subject Satisfaction Survey question for control subject's: Past IV starts have been difficult, uncomfortable or painful.
time frame: Day 0 after completion of the study procedure
description: Control subject's assessment of pain associated with past IV starts:
Scale 1 - 5; Unable to Evaluate
Strongly Agree
Agree
Neutral
Disagree
Strongly Disagree Unable to Evaluate
measure: Subject Satisfaction Survey question for control subject's: Today, my IV was started easily.
time frame: Day 0 after completion of the study procedure
description: Control subject's assessment of how easy they believe today's IV start was:
Scale 1 - 5; Unable to Evaluate
Strongly Agree
Agree
Neutral
Disagree
Strongly Disagree Unable to Evaluate
measure: Subject Satisfaction Survey question for control subject's: Pain associated with IV start procedure today.
time frame: Day 0 after completion of the study procedure
description: Control subject's assessment of pain level associated with today's IV start procedure:
Scale 1 - 5; Unable to Evaluate
Not painful at all
Almost no pain
Some pain
Moderate pain
Extreme pain Unable to Evaluate
measure: Subject Satisfaction Survey question for control subject's: Pain associated with today's IV start compared to past IV starts.
time frame: Day 0 after completion of the study procedure
description: Control subject's assessment of pain associated with today's IV start compared to past IV starts:
Scale 1 - 5; Unable to Evaluate
Much less pain
Less Painful
Equal Pain
More Painful
Much More Painful Unable to Evaluate
measure: Subject Satisfaction Survey question for control subject's: Anxiety associated with the IV start procedure today.
time frame: Day 0 after completion of the study procedure
description: Control subject's assessment of anxiety level associated with today's IV start procedure:
Scale 1 - 5; Unable to Evaluate
Not Anxious
Slightly Anxious
Anxious
Moderately Anxious
Very Anxious Unable to Evaluate
measure: Subject Satisfaction Survey question for control subject's: Anxiety associated with today's IV start compared to past IV starts.
time frame: Day 0 after completion of the study procedure
description: Control subject's assessment of anxiety level associated with today's IV start procedure compared to past IV starts:
Scale 1 - 5; Unable to Evaluate
A Lot Less Anxious
Less Anxious
The Same
More Anxious
Very Anxious Unable to Evaluate
measure: Subject Satisfaction Survey question for control subject's: Overall, I was satisfied with today's IV start.
time frame: Day 0 after completion of the study procedure
description: Control subject's overall assessment of satisfaction with today's IV start:
Scale 1 - 5; Unable to Evaluate
Strongly Agree
Agree
Neutral
Disagree
Strongly Disagree Unable to Evaluate
measure: Subject Satisfaction Survey question for treatment subject's: Past IV starts have been difficult, uncomfortable or painful.
time frame: Day 0 after completion of the study procedure
description: Veinplicity subject's assessment of pain associated with past IV starts:
Scale 1 - 5; Unable to Evaluate
Strongly Agree
Agree
Neutral
Disagree
Strongly Disagree Unable to Evaluate
measure: Subject Satisfaction Survey question for treatment subject's: Today, my IV was started easily.
time frame: Day 0 after completion of the study procedure
description: Veinplicity subject's assessment of how easy they believe today's IV start was:
Scale 1 - 5; Unable to Evaluate
Strongly Agree
Agree
Neutral
Disagree
Strongly Disagree Unable to Evaluate
measure: Subject Satisfaction Survey question for treatment subject's: Pain associated with IV start procedure today.
time frame: Day 0 after completion of the study procedure
description: Veinplicity subject's assessment of pain level associated with today's IV start procedure:
Scale 1 - 5; Unable to Evaluate
Not painful at all
Almost no pain
Some pain
Moderate pain
Extreme pain Unable to Evaluate
measure: Subject Satisfaction Survey question for treatment subject's: Pain associated with today's IV start compared to past IV starts.
time frame: Day 0 after completion of the study procedure
description: Veinplicity subject's assessment of pain level associated with today's IV start compared to past IV starts:
Scale 1 - 5; Unable to Evaluate
Not painful at all
Almost no pain
Some pain
Moderate pain
Extreme pain Unable to Evaluate
measure: Subject Satisfaction Survey question for treatment subject's: Anxiety associated with the IV start procedure today.
time frame: Day 0 after completion of the study procedure
description: Veinplicity subject's assessment of anxiety level associated with today's IV start procedure:
Scale 1 - 5; Unable to Evaluate
Not Anxious
Slightly Anxious
Anxious
Moderately Anxious
Very Anxious Unable to Evaluate
measure: Subject Satisfaction Survey question for treatment subject's: Anxiety associated with today's IV start compared to past IV starts.
time frame: Day 0 after completion of the study procedure
description: Veinplicity subject's assessment of anxiety level associated with today's IV start procedure compared to past IV starts:
Scale 1 - 5; Unable to Evaluate
A Lot Less Anxious
Less Anxious
The Same
More Anxious
Very Anxious Unable to Evaluate
measure: Subject Satisfaction Survey question for treatment subject's: Pain associated with the Veinplicity stimulation.
time frame: Day 0 after completion of the study procedure
description: Veinplicity subject's assessment on level of pain associated with today's Veinplicity stimulation:
Scale 1 - 5; Unable to Evaluate
Not painful at all
Almost no pain
Some pain
Moderate pain
Extreme pain Unable to Evaluate
measure: Subject Satisfaction Survey question for treatment subject's: Veinplicity improved the overall success of my experience.
time frame: Day 0 after completion of the study procedure
description: Veinplicity subject's assessment on how Veinplicity improved overall success of their experience today:
Strongly Agree
Agree
Neutral
Disagree
Strongly Disagree Unable to Evaluate
measure: Subject Satisfaction Survey question for treatment subject's: The Veinplicity device made it easier for the nurse to find a vein for my IV start today.
time frame: Day 0 after completion of the study procedure
description: Veinplicity subject's assessment of Veinplicity device made it easier for nurse to find a vein for today's IV start:
Strongly Agree
Agree
Neutral
Disagree
Strongly Disagree Unable to Evaluate
measure: Subject Satisfaction Survey question for treatment subject's: I would choose the Veinplicity again for future IV starts.
time frame: Day 0 after completion of the study procedure
description: Veinplicity subject's likelihood of choosing to use the Veinplicity device for future IV starts:
Definitely Agree
Agree
Neutral
Disagree
Definitely Disagree Unable to Evaluate
measure: Subject Satisfaction Survey question for treatment subject's: Overall, I was satisfied with today's IV start.
time frame: Day 0 after completion of the study procedure
description: Veinplicity subject's overall assessment of satisfaction with today's IV start:
Scale 1 - 5; Unable to Evaluate
Strongly Agree
Agree
Neutral
Disagree
Strongly Disagree Unable to Evaluate
measure: Clinician satisfaction
time frame: Assessed on Day 0 after completion of the study procedure
description: On Day 0 after each Veinplicity subject's IV procedure, each clinician will complete a Clinician Satisfaction Survey, after cannulation has been attempted and subject is declared either a study success or failure. Clinician's are not to complete this survey for control subjects.
Scale 1 to 5:
= Strongly Agree
= Moderately Agree
= Neutral
= Moderately Disagree
= Strongly Disagree QUESTION 1: Veinplicity was easy to use. QUESTION 2: Veinplicity improved vein palpability. QUESTION 3: Veinplicity improved vein visualization. QUESTION 4: Veinplicity made it easier to identify a suitable vessel to access.
QUESTION 5: Veinplicity improved the overall success of the experience. QUESTION 6: Veinplicity resulted in a more positive and less anxious experience for the patient.
QUESTION 7: I would recommend Veinplicity to a colleague or patient. QUESTION 8: Overall, I was satisfied with using the Veinplicity device.
measure: Change in the vein quality score from baseline to pre-cannulation tourniquet application
time frame: Day 0
description: scores at baseline and post-stimulation to be assessed at time of tourniquet application by the same clinician.
Scale = Vessel Health and Preservation (VHP) Peripheral Vein Assessment Scale. Grade 1 = Vein Quality Excellent (4-5 palpable/easily visible veins suitable to cannulate) Grade 2 = Vein Quality Good (2-3 palpable/visible veins suitable to cannulate Grade 3 = Vein Quality Fair (1-2 palpable/visible veins suitable to cannulate [veins may be small, scarred or difficult to find and require heat packs to aid vasodilation]) Grade 4 = Vein Quality Poor (veins not palpable/visible [requires ultrasound assistance or infrared viewer]) Grade 5 = Vein Quality None identifiable (no visible [naked eye or aids] or palpable veins) Fair or Poor indicates to clinician that cannulation may be challenging and require extra time or resources; use of Veinplicity may increase vessel size and improve identification of vessels suitable for cannulation
arm group label: Veinplicity with tourniquet (treatment)
arm group type: Experimental
description: Veinplicity with tourniquet
arm group label: Tourniquet (control)
arm group type: Active Comparator
description: Control: Tourniquet
intervention type: Device
intervention name: Veinplicity with tourniquet
description: Veinplicity will be used with a tourniquet
arm group label: Veinplicity with tourniquet (treatment)
intervention type: Device
intervention name: Tourniquet
description: A tourniquet alone will be used.
arm group label: Tourniquet (control)
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Gregory J Schears, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor