Veinplicity for Improved Venous Access: The VIVA Trial (NCT03752632) | Clinical Trial Compass
TerminatedPhase 3
Veinplicity for Improved Venous Access: The VIVA Trial
Stopped: Business reasons not related to safety or trial conduct
United States120 participantsStarted 2018-11-01
Plain-language summary
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.
Who can participate
Age range22 Years
SexALL
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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.
What they're measuring
1
First-stick success when accessing a peripheral vein for cannulation