Assess Veinplicity Venous Access Device Safety and Effectiveness

Physeon

Status: Completed

Conditions: Phlebotomy

Treatments: Device: Stimulation-assisted venous access; Other: 20 guage cannula for IV, tourniquet optional

Study type: Interventional

Funder types: Industry

Identifiers

NCT03109405

292-13-280681

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

stimulation-assisted

Experimental group

Description:

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.

Treatment:

Other: 20 guage cannula for IV, tourniquet optional

Device: Stimulation-assisted venous access

standard IV cannulation

Other group

Description:

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.

Treatment:

Other: 20 guage cannula for IV, tourniquet optional