RIGHT IV Pilot Study
RIGHT IV
Post-Market Study Comparing the Clinical Performance Two Blood Control Safety Peripheral Intravenous Catheters: A Pilot Study
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 8, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedMay 26, 2016
May 1, 2014
Same day
February 8, 2013
May 25, 2016
Conditions
Keywords
Outcome Measures
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.
IV catheters will be inserted, secured to subjects, and then immediately removed. Data regarding the insertion process will then be immediately collected.
Study Arms (2)
ViaValve Safety IV Catheter
ACTIVE COMPARATORCatheter insertion using the ViaValve Safety IV Catheter.
Insyte Autoguard BC [Blood Control] Shielded IV Catheter
ACTIVE COMPARATORCatheter insertion using the Insyte Autoguard BC Shielded IV Catheter
Interventions
Insertion of the peripheral intravenous catheters into both upper extremities of subjects
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota Interprofessional Education and Resource Center
Minneapolis, Minnesota, 55455, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Lori Schwartz, MBA, MSN, RN, PHN
Smiths Medical
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2013
First Posted
February 15, 2013
Study Start
February 1, 2013
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
May 26, 2016
Record last verified: 2014-05