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OpenTrials
Completed

NCT Number: NCT03109405

Assess Veinplicity Venous Access Device Safety and Effectiveness

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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Key information

Conditions

Phlebotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stimulation-assisted venous access

Device

Stimulation-assisted venous access

Other names: Veinplicity Device

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

Primary outcomes

  1. Rate of successful venous access on the first attempt.

    Time frame: 7 days

  2. Rate of adverse events associated with either the treatment or the venous access site.

    Time frame: 7 days

Secondary outcomes

  1. User Perception of IV cannulation difficulty,

    Time frame: 7 days

  2. Subject Preception of IV cannulation pain

    Time frame: 7 days

  3. Subject Perception of Device stimulation

    Time frame: 7 days

  4. Time required to achieve successful IV cannula placement

    Time frame: time from initial puncture to successful IV cannulation

  5. Number of attempts required to achieve successful IV cannula placement

    Time frame: over a 24 hour period

    number of punctures from initial puncture to successful IV cannulation

Sponsors and collaborators

Lead sponsor

Physeon GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 12, 2017
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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