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

Tracking Information

First Received Date ^ICMJE

June 1, 2009

Last Updated Date

November 2, 2012

Start Date ^ICMJE

June 2009

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00914069 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Vascular Access Complication

Intervention ^ICMJE

Device: RIVS vascular access
Access to peripheral vasculature
Device: Conventional vascular access
Vascular access using conventional venous access device

Study Arm (s)

Experimental: RIVS vascular access
RIVS vascular access

Intervention: Device: RIVS vascular access
Active Comparator: Conventional vascular access
Conventional vascular access

Intervention: Device: Conventional vascular access

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

175

Estimated Completion Date

March 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

5 Years to 90 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00914069

Other Study ID Numbers ^ICMJE

62009123

Has Data Monitoring Committee

Yes

Responsible Party

Vascular Pathways, Inc.

Study Sponsor ^ICMJE

Vascular Pathways, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jeffrey S Stuart, MD

Washington Outpatient Surgery Center

Information Provided By

Vascular Pathways, Inc.

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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