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RIGHT IV Pilot Study (RIGHT IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01792778
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Smiths Medical, ASD, Inc.

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.

Condition or disease Intervention/treatment Phase
Peripheral Intravenous Catheters Device: ViaValve Safety IV Catheter Device: Insyte Autoguard BC [Blood Control] Shielded IV Catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Post-Market Study Comparing the Clinical Performance Two Blood Control Safety Peripheral Intravenous Catheters: A Pilot Study
Study Start Date : February 2013
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Active Comparator: ViaValve Safety IV Catheter
Catheter insertion using the ViaValve Safety IV Catheter.
Device: ViaValve Safety IV Catheter
Insertion of the peripheral intravenous catheters into both upper extremities of subjects

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



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792778


Locations
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United States, Minnesota
University of Minnesota Interprofessional Education and Resource Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Smiths Medical, ASD, Inc.
Investigators
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Principal Investigator: Lori Schwartz, MBA, MSN, RN, PHN Smiths Medical

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Responsible Party: Smiths Medical, ASD, Inc.
ClinicalTrials.gov Identifier: NCT01792778    
Other Study ID Numbers: RIGHT IV Pilot Study
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2014
Keywords provided by Smiths Medical, ASD, Inc.:
IV Catheters
Blood control