Assess Veinplicity Venous Access Device Safety and Effectiveness

NCT03109405 | Completed

• 1 other identifier: 292-13-280681
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Phlebotomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

  over a 24 hour period

Study Arms (2)

stimulation-assisted

EXPERIMENTAL

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; Other: 20 guage cannula for IV, tourniquet optional

standard IV cannulation

OTHER

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

Interventions

Stimulation-assisted venous access DEVICE

Stimulation-assisted venous access

Also known as: Veinplicity Device

stimulation-assisted

20 guage cannula for IV, tourniquet optional OTHER

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

standard IV cannulation; stimulation-assisted

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Physeon GmbH: lead

Study Officials

• Leela Vrishabhendra, MD

  Medpace Medical Device

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 12, 2017
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share