Veinplicity for Improved Venous Access: The VIVA Trial
Stopped early · Phase 3
Conditions studied: Difficult-to-access Veins for Intravenous Cannulation
In brief
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.
Key facts
- Study ID
- NCT03752632
- Run by
- Physeon GmbH
- People needed
- 120
- Starts
- 2018-11-01
- Expected to finish
- 2019-07-22
- Last updated by the study team
- 2019-10-30
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Midwest Immunology Clinic and Infusion Center — Plymouth, Minnesota, United States
- Mayo Clinic-Rochester — Rochester, Minnesota, United States
- Regions Hospital — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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