Veinplicity for Improved Venous Access: The VIVA Trial

NCT03752632 | Terminated Phase 3 FDA Device

• 1 other identifier: PHY0011
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Difficult-to-access Veins for Intravenous Cannulation

Keywords

intravenous; peripheral vein; cannulation; IV access

Outcome Measures

Primary Outcomes (2)

• First-stick success when accessing a peripheral vein for cannulation

  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

  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 Outcomes (23)

• Number of attempted sticks to successful vein access

  Day 0

• Total procedure time

  Day 0

• Time to first-stick success

  Day 0

Study Arms (2)

Veinplicity with tourniquet (treatment)

EXPERIMENTAL

Veinplicity with tourniquet

Device: Veinplicity with tourniquet

Tourniquet (control)

ACTIVE COMPARATOR

Control: Tourniquet

Device: Tourniquet

Interventions

Veinplicity with tourniquet DEVICE

Veinplicity will be used with a tourniquet

Veinplicity with tourniquet (treatment)

Tourniquet DEVICE

A tourniquet alone will be used.

Tourniquet (control)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Physeon GmbH: lead
• Regulatory and Clinical Research Institute Inc: collaborator

Study Sites (3)

Midwest Immunology Clinic and Infusion Center

Plymouth, Minnesota, 55446, United States

Location

Mayo Clinic-Rochester

Rochester, Minnesota, 55905, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

MeSH Terms

Interventions

Tourniquets

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Gregory J Schears, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 26, 2018
• Study Start: November 1, 2018
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: October 30, 2019

Record last verified: 2019-10

Locations

US (3)