Veinplicity for Improved Venous Access: The VIVA Trial

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.

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.