Assess Veinplicity Venous Access Device Safety and Effectiveness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Phlebotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Stimulation-assisted venous access

Intervention Type DEVICE

Stimulation-assisted venous access

20 guage cannula for IV, tourniquet optional

Intervention Type OTHER

Standard IV cannulation using 20 ga needle, and use of tourniquet at discretion of nurse performing IV cannulation

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.

Group Type OTHER

20 guage cannula for IV, tourniquet optional

Intervention Type OTHER

Standard IV cannulation using 20 ga needle, and use of tourniquet at discretion of nurse performing IV cannulation

Interventions

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Stimulation-assisted venous access

Intervention Type DEVICE

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

Intervention Type OTHER

Other Intervention Names

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Veinplicity Device

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No