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CompletedNCT01792778RIGHT IVUpdated May 26, 2016

RIGHT IV Pilot Study

An interventional study of ViaValve Safety IV Catheter and Insyte Autoguard BC [Blood Control] Shielded IV Catheter in Peripheral Intravenous Catheters, sponsored by Smiths Medical, ASD, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-26.

Sponsored by Smiths Medical, ASD, Inc. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Peripheral Intravenous Catheters

Keywords

  • IV Catheters
  • Blood control
03

In context

Lead sponsor

Smiths Medical, ASD, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 years of age or older
  • Willing and able to independently sign an English Informed Consent
  • Have adequate veins for placement of IV catheters in both right and left upper extremities

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    ViaValve Safety IV Catheter

    Catheter insertion using the ViaValve Safety IV Catheter.

    Device: ViaValve Safety IV Catheter

  • Active comparator
    Insyte Autoguard BC [Blood Control] Shielded IV Catheter

    Catheter insertion using the Insyte Autoguard BC Shielded IV Catheter

    Device: Insyte Autoguard BC [Blood Control] Shielded IV Catheter

Interventions

  • DeviceViaValve Safety IV Catheter

    Insertion of the peripheral intravenous catheters into both upper extremities of subjects

  • DeviceInsyte Autoguard BC [Blood Control] Shielded IV Catheter
06

What researchers measure

Primary outcomes

  1. Clinical performance and acceptability

    Primary outcome measure will be a composite of user ratings evaluating clinical performance and acceptability of each device via a 6-point Likert questionnaire.

    Time frame: IV catheters will be inserted, secured to subjects, and then immediately removed. Data regarding the insertion process will then be immediately collected.

07

Study locations

1 site
  • University of Minnesota Interprofessional Education and Resource Center
    Minneapolis, Minnesota 55455, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01792778
Lead sponsor
Smiths Medical, ASD, Inc.
Responsible party
Sponsor
First posted
Feb 15, 2013
Start date
Feb 2013
Primary completion
Feb 2013
Completion
Feb 2013
Last update
May 26, 2016

Study contacts

Lori Schwartz, MBA, MSN, RN, PHN
principal investigator · Smiths Medical

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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