Veinplicity for Improved Venous Access: The VIVA Trial

October 28, 2019 updated by: Physeon GmbH
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Midwest Immunology Clinic and Infusion Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic-Rochester
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is ≥ 22 years old.
  • Subject is assessed as having fair or poor vein quality.
  • Subject's both arms are suitable for cannulation.
  • Subject will not suffer harm from a delay in having an IV established as determined by the treating clinician.

Exclusion Criteria:

  • Subject has existing intravenous access.
  • Subject has a planned or existing intra-arterial access.
  • Subject has broken, infected or irritated skin and/or dermatological conditions, e.g., eczema, psoriasis and/or allergic reactions, on either forearm.
  • Subject has an active implantable medical device.
  • Subject wears a transdermal drug delivery patch on her/his forearm.
  • Subject has an active/suspected deep vein thrombosis or thrombophlebitis, impaired circulation, impaired sensation, active/uncontrolled bleeding, recently radiated tissue, recent fracture, recent injury or surgery resulting in blood loss > 100 mL, osteoporosis, localized abscess, localized tuberculosis, and/or a chronic wound with potential underlying osteomyelitis.
  • Subject has impaired cognition or communication (unable to provide accurate feedback).
  • Subject has a history of seizures and/or epilepsy, and/or a recent seizure, possible recent seizure or a history of possible seizures.
  • Subject is pregnant and/or breastfeeding at the time of study enrollment.
  • Subject has, at the site of or in between Veinplicity electrode application sites, an active/suspected malignancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Veinplicity with tourniquet (treatment)
Veinplicity with tourniquet
Device: Veinplicity with tourniquet
Veinplicity will be used with a tourniquet
ACTIVE_COMPARATOR: Tourniquet (control)
Control: Tourniquet
Device: Tourniquet
A tourniquet alone will be used.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
First-stick success when accessing a peripheral vein for cannulation
Time Frame: Day 0
successful peripheral vein access for the first-stick with use of Veinplicity with tourniquet versus tourniquet alone
Day 0
Device and/or procedure-related adverse events
Time Frame: Day 1
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.
Day 1

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of attempted sticks to successful vein access
Time Frame: Day 0
Number of attempted sticks to successful vein access
Day 0
Total procedure time
Time Frame: Day 0
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.
Day 0
Time to first-stick success
Time Frame: Day 0
time from tourniquet application for the initial cannulation attempt to declaration of first-stick success/failure.
Day 0
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

Control subject's assessment of pain associated with past IV starts:

Scale 1 - 5; Unable to Evaluate

  1. Strongly Agree
  2. Agree
  3. Neutral
  4. Disagree
  5. Strongly Disagree Unable to Evaluate
Day 0 after completion of the study procedure
Subject Satisfaction Survey question for control subject's: Today, my IV was started easily.
Time Frame: Day 0 after completion of the study procedure

Control subject's assessment of how easy they believe today's IV start was:

Scale 1 - 5; Unable to Evaluate

  1. Strongly Agree
  2. Agree
  3. Neutral
  4. Disagree
  5. Strongly Disagree Unable to Evaluate
Day 0 after completion of the study procedure
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

Control subject's assessment of pain level associated with today's IV start procedure:

Scale 1 - 5; Unable to Evaluate

  1. Not painful at all
  2. Almost no pain
  3. Some pain
  4. Moderate pain
  5. Extreme pain Unable to Evaluate
Day 0 after completion of the study procedure
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

Control subject's assessment of pain associated with today's IV start compared to past IV starts:

Scale 1 - 5; Unable to Evaluate

  1. Much less pain
  2. Less Painful
  3. Equal Pain
  4. More Painful
  5. Much More Painful Unable to Evaluate
Day 0 after completion of the study procedure
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

Control subject's assessment of anxiety level associated with today's IV start procedure:

Scale 1 - 5; Unable to Evaluate

  1. Not Anxious
  2. Slightly Anxious
  3. Anxious
  4. Moderately Anxious
  5. Very Anxious Unable to Evaluate
Day 0 after completion of the study procedure
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

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

  1. A Lot Less Anxious
  2. Less Anxious
  3. The Same
  4. More Anxious
  5. Very Anxious Unable to Evaluate
Day 0 after completion of the study procedure
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

Control subject's overall assessment of satisfaction with today's IV start:

Scale 1 - 5; Unable to Evaluate

  1. Strongly Agree
  2. Agree
  3. Neutral
  4. Disagree
  5. Strongly Disagree Unable to Evaluate
Day 0 after completion of the study procedure
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

Veinplicity subject's assessment of pain associated with past IV starts:

Scale 1 - 5; Unable to Evaluate

  1. Strongly Agree
  2. Agree
  3. Neutral
  4. Disagree
  5. Strongly Disagree Unable to Evaluate
Day 0 after completion of the study procedure
Subject Satisfaction Survey question for treatment subject's: Today, my IV was started easily.
Time Frame: Day 0 after completion of the study procedure

Veinplicity subject's assessment of how easy they believe today's IV start was:

Scale 1 - 5; Unable to Evaluate

  1. Strongly Agree
  2. Agree
  3. Neutral
  4. Disagree
  5. Strongly Disagree Unable to Evaluate
Day 0 after completion of the study procedure
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

Veinplicity subject's assessment of pain level associated with today's IV start procedure:

Scale 1 - 5; Unable to Evaluate

  1. Not painful at all
  2. Almost no pain
  3. Some pain
  4. Moderate pain
  5. Extreme pain Unable to Evaluate
Day 0 after completion of the study procedure
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

Veinplicity subject's assessment of pain level associated with today's IV start compared to past IV starts:

Scale 1 - 5; Unable to Evaluate

  1. Not painful at all
  2. Almost no pain
  3. Some pain
  4. Moderate pain
  5. Extreme pain Unable to Evaluate
Day 0 after completion of the study procedure
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

Veinplicity subject's assessment of anxiety level associated with today's IV start procedure:

Scale 1 - 5; Unable to Evaluate

  1. Not Anxious
  2. Slightly Anxious
  3. Anxious
  4. Moderately Anxious
  5. Very Anxious Unable to Evaluate
Day 0 after completion of the study procedure
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

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

  1. A Lot Less Anxious
  2. Less Anxious
  3. The Same
  4. More Anxious
  5. Very Anxious Unable to Evaluate
Day 0 after completion of the study procedure
Subject Satisfaction Survey question for treatment subject's: Pain associated with the Veinplicity stimulation.
Time Frame: Day 0 after completion of the study procedure

Veinplicity subject's assessment on level of pain associated with today's Veinplicity stimulation:

Scale 1 - 5; Unable to Evaluate

  1. Not painful at all
  2. Almost no pain
  3. Some pain
  4. Moderate pain
  5. Extreme pain Unable to Evaluate
Day 0 after completion of the study procedure
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

Veinplicity subject's assessment on how Veinplicity improved overall success of their experience today:

  1. Strongly Agree
  2. Agree
  3. Neutral
  4. Disagree
  5. Strongly Disagree Unable to Evaluate
Day 0 after completion of the study procedure
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

Veinplicity subject's assessment of Veinplicity device made it easier for nurse to find a vein for today's IV start:

  1. Strongly Agree
  2. Agree
  3. Neutral
  4. Disagree
  5. Strongly Disagree Unable to Evaluate
Day 0 after completion of the study procedure
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

Veinplicity subject's likelihood of choosing to use the Veinplicity device for future IV starts:

  1. Definitely Agree
  2. Agree
  3. Neutral
  4. Disagree
  5. Definitely Disagree Unable to Evaluate
Day 0 after completion of the study procedure
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

Veinplicity subject's overall assessment of satisfaction with today's IV start:

Scale 1 - 5; Unable to Evaluate

  1. Strongly Agree
  2. Agree
  3. Neutral
  4. Disagree
  5. Strongly Disagree Unable to Evaluate
Day 0 after completion of the study procedure
Clinician satisfaction
Time Frame: Assessed on Day 0 after completion of the study procedure

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:

  1. = Strongly Agree
  2. = Moderately Agree
  3. = Neutral
  4. = Moderately Disagree
  5. = 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.
Assessed on Day 0 after completion of the study procedure
Change in the vein quality score from baseline to pre-cannulation tourniquet application
Time Frame: Day 0

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
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Physeon GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regulatory Clinical Research Institute (RCRI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gregory J Schears, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHY0011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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