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Assess Veinplicity Venous Access Device Safety and Effectiveness

NCT03109405 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-04-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Physeon GmbH

    lead INDUSTRY

Principal Investigators

  • Leela Vrishabhendra, MD · Medpace Medical Device

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-08-31
Completion
2015-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03109405 on ClinicalTrials.gov