Completed
RIGHT IVPost-Market Study Comparing the Clinical Performance Two Blood Control Safety Peripheral Intravenous Catheters: A Pilot Study
What is being tested
ViaValve Safety IV Catheter
+ Insyte Autoguard BC [Blood Control] Shielded IV Catheter
Device
Who is being recruted
Over 18 Years
+7 Eligibility Criteria
How is the trial designed
Supportive Care Study
Interventional
Study Start: February 2013
Summary
Principal SponsorSmiths Medical, ASD, Inc.
Last updated: May 26, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2013
Actual date on which the first participant was enrolled.The purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous catheters.
Principal SponsorSmiths Medical, ASD, Inc.
Last updated: May 26, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
18 years of age or older
Have adequate veins for placement of IV catheters in both right and left upper extremities
Willing and able to independently sign an English Informed Consent
4 exclusion criteria prevent from participating
Currently taking anti-coagulation medication
Have a known bloodborne disease or bleeding tendency
Have a known fear or adverse reaction to needles or blood
Women who are pregnant or nursing
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorCatheter insertion using the ViaValve Safety IV Catheter.
Group II
Active ComparatorCatheter insertion using the Insyte Autoguard BC Shielded IV Catheter
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Minnesota Interprofessional Education and Resource Center
Minneapolis, United StatesOpen University of Minnesota Interprofessional Education and Resource Center in Google MapsCompletedOne Study Center