Status:
TERMINATED
Veinplicity for Improved Venous Access: The VIVA Trial
Lead Sponsor:
Physeon GmbH
Collaborating Sponsors:
Regulatory and Clinical Research Institute Inc
Conditions:
Difficult-to-access Veins for Intravenous Cannulation
Eligibility:
All Genders
22+ years
Phase:
PHASE3
Brief 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.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03752632
Start Date
November 1 2018
End Date
July 22 2019
Last Update
October 30 2019
Active Locations (3)
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1
Midwest Immunology Clinic and Infusion Center
Plymouth, Minnesota, United States, 55446
2
Mayo Clinic-Rochester
Rochester, Minnesota, United States, 55905
3
Regions Hospital
Saint Paul, Minnesota, United States, 55101