Assess Veinplicity Venous Access Device Safety and Effectiveness

Phlebotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109405
• Other study ID #: 292-13-280681
• Status: Completed
• Phase: N/A
• First received: April 21, 2016
• Last updated: April 3, 2018
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: April 2018
• Source: Physeon GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Phlebotomy

Intervention

Device:
• Stimulation-assisted venous access
Stimulation-assisted venous access

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Physeon GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful venous access on the first attempt.		7 days
Primary	Rate of adverse events associated with either the treatment or the venous access site.		7 days
Secondary	User Perception of IV cannulation difficulty,		7 days
Secondary	Subject Preception of IV cannulation pain		7 days
Secondary	Subject Perception of Device stimulation		7 days
Secondary	Time required to achieve successful IV cannula placement		time from initial puncture to successful IV cannulation
Secondary	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