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

Smiths Medical, ASD, Inc.1 site in 1 country40 target enrollmentFebruary 2013

ConditionsPeripheral Intravenous Catheters

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Intravenous Catheters
Sponsor: Smiths Medical, ASD, Inc.
Enrollment: 40
Locations: 1
Primary Endpoint: Clinical performance and acceptability
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

February 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Smiths Medical, ASD, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.