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Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter

This study has been terminated.
(Funding Stopped)
Sponsor:
Information provided by (Responsible Party):
Vascular Pathways, Inc.
ClinicalTrials.gov Identifier:
NCT00914069
First received: June 1, 2009
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.


Condition Intervention
Vascular Access Complication
 Device: RIVS vascular access
Device: Conventional vascular access

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of the Safety and Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter for Peripheral Intravenous (PIV) Insertion in Children, Oncology Patients and Elderly: a Controlled Randomized Trial

Further study details as provided by Vascular Pathways, Inc.:

Primary Outcome Measures:
  • First attempt IV success rate, time of procedure [ Time Frame: Immediate peri-procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of attempts required to complete a successful IV start [ Time Frame: Immediate peri-procedure ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: June 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RIVS vascular access
RIVS vascular access
 Device: RIVS vascular access
Access to peripheral vasculature
Active Comparator: Conventional vascular access
Conventional vascular access
 Device: Conventional vascular access
Vascular access using conventional venous access device

Detailed Description:

The hypothesis to be statistically tested was that the RIVS system will have a higher rate of successful first attempt peripheral intravenous placement success as compared to conventional peripheral intravenous catheters without a significant increase in device related complications and procedure time.

  Eligibility

Ages Eligible for Study:   5 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Any type of oncology patients undergoing chemotherapy or post-chemotherapy (without a port/cannula), or over 65 years
  • Requires peripheral IV as determined by examining physician
  • Requires the IV when a study nurse or resident is available
  • Able to sign an informed consent

Exclusion Criteria

  • Active systemic or cutaneous infection or inflammation;
  • Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
  • Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
  • Currently involved in any other investigational clinical trials;
  • Previous vascular grafts or surgery at the target vessel access site;
  • Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
  • Central line available
  • Requirement for immediate IV placement (patient's condition would potentially be compromised if there is a time delay in IV placement)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914069

Locations
United States, California
Washington Outpatient Surgery Center
Fremont, California, United States, 94538
United States, Florida
St. Vincent's Medical Center
Jacksonville, Florida, United States, 32204
United States, Ohio
University Hospital Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Vascular Pathways, Inc.
Investigators
Principal Investigator: Jeffrey S Stuart, MD Washington Outpatient Surgery Center
  More Information

No publications provided

Responsible Party: Vascular Pathways, Inc.
ClinicalTrials.gov Identifier: NCT00914069     History of Changes
Other Study ID Numbers: 62009123
Study First Received: June 1, 2009
Last Updated: November 2, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013