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Completed

NCT Number: NCT01792778

RIGHT IV Pilot Study

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.

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Key information

Conditions

Peripheral Intravenous Catheters

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Interprofessional Education and Resource Center

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

  • 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

Treatment and study plan

ViaValve Safety IV Catheter

Device

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

Insyte Autoguard BC [Blood Control] Shielded IV Catheter

Device

Primary outcomes

  1. Clinical performance and acceptability

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

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

Sponsors and collaborators

Lead sponsor

Smiths Medical, ASD, Inc.

Industry

Registry information

Official study title

Post-Market Study Comparing the Clinical Performance Two Blood Control Safety Peripheral Intravenous Catheters: A Pilot Study

Acronym: RIGHT IV

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 15, 2013
Registry last updated
May 26, 2016

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.