Assess Veinplicity Venous Access Device Safety and Effectiveness

A Prospective, Single Center, Randomized, Cross-over Clinical Trial to Assess the Safety and Effectiveness of the Veinplicity Venous Access Device

The purpose of this study was to examine the Veinplicity Device as an adjunctive IV cannulation tool in subjects with a history of difficult to access veins. The Veinplicity Device is intended to improve venous access rates in compromised patients by taking advantage of the increased circulation that results from provoked muscle stimulation. The study collected information about the device, intravenous access, user and patient perceptions for IV access, and any device or procedural complications or other adverse events. Device use was examined with patients in both a prone and upright position.

Study Overview

• Status: Completed
• Conditions: Phlebotomy
• Intervention / Treatment: Device: Stimulation-assisted venous access; Other: 20 guage cannula for IV, tourniquet optional

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject ≥ 18 years of age
• Subject with history of failed venous access, venipuncture, or IV cannula placement
• Subject agreed to required follow-up
• Subject provided written, informed consent

Exclusion Criteria:

• Subject currently had compromised skin on either forearm or hand
• Subject currently on any blood thinning medication other than 81mg of aspirin
• Subject had been diagnosed with peripheral neuropathy, has had a complex fracture or surgery in the forearm, or has other condition that diminishes sensation in one or both arms, hands or fingers
• Subject had a demand type pacemaker or defibrillator
• Subject is female of child-bearing potential and had a positive urine pregnancy test
• Subject had a history of seizure, convulsions or epilepsy
• Subject had a known allergy to Epsom salts
• Subject had any other condition that may affect the ability to complete study requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stimulation-assisted; All subjects received treatment (stimulation-assisted) with the Veinplicity Device per the Instructions for Use. The subject underwent standard IV cannulation using a 20 gauge cannula into the available vein immediately after completion of device stimulation. Use of a tourniquet was at the discretion of the nurse performing the IV cannulation.	Device: Stimulation-assisted venous access; Stimulation-assisted venous access; Other Names: Veinplicity Device; Other: 20 guage cannula for IV, tourniquet optional; Standard IV cannulation using 20 ga needle, and use of tourniquet at discretion of nurse performing IV cannulation
Other: standard IV cannulation; The subject underwent standard IV cannulation using a 20 gauge cannula into the best available vein. Use of a tourniquet was at the discretion of the nurse performing the IV cannulation.	Other: 20 guage cannula for IV, tourniquet optional; Standard IV cannulation using 20 ga needle, and use of tourniquet at discretion of nurse performing IV cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of successful venous access on the first attempt.	7 days
Rate of adverse events associated with either the treatment or the venous access site.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Perception of IV cannulation difficulty,		7 days
Subject Preception of IV cannulation pain		7 days
Subject Perception of Device stimulation		7 days
Time required to achieve successful IV cannula placement		time from initial puncture to successful IV cannulation
Number of attempts required to achieve successful IV cannula placement	number of punctures from initial puncture to successful IV cannulation	over a 24 hour period

Collaborators and Investigators

• Sponsor: Physeon GmbH
• Investigators: Principal Investigator: Leela Vrishabhendra, MD, Medpace Medical Device

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 292-13-280681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No