A Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter (ViaValve-001)

April 18, 2014 updated by: Smiths Medical, ASD, Inc.

A Post-market, Randomized Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter

The objective of this post-market, prospective study is to evaluate the clinical acceptability, blood leakage, risk for blood exposure, need for digital compression, insertion success, and clinical utility of the ViaValve™ Safety IV Catheter compared to standard hospital PIVCs currently being used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Foothills Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A peripheral intravenous catheter will need to be inserted in order to gain access to a vein or artery to sample blood, monitor blood pressure, or administer fluids intravenous infusion as part of treatment.
  • Willing and able to sign an Informed Consent (patient or legally authorized representative).

Exclusion Criteria:

  • Body morphology (e.g., size) precludes the use of a peripheral intravenous catheter.
  • Fluid to be infused is not appropriate for peripheral intravenous catheters.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ViaValve™ Safety IV Catheter
Insertion of the ViaValve™ Safety IV Catheter
Device: ViaValve™ Safety IV Catheter
Safety peripheral IV catheter with a blood control feature
ACTIVE_COMPARATOR: ProtectIV® Plus Safety IV Catheter
Insertion of the ProtectIV® Plus Safety IV Catheter
Device: ProtectIV® Plus Safety IV Catheter
Safety peripheral IV catheter with no blood control feature

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical acceptability of PIVC insertion
Time Frame: Clinicians will provide the rating immediately after performing the insertion
Demonstrate non-inferiority of the ViaValve™ Safety I.V. Catheter compared to the control PIVC for ratings of clinical acceptability. Clinicians will agree or disagree that the device was clinically acceptable for the insertion.
Clinicians will provide the rating immediately after performing the insertion
Frequency of blood leakage
Time Frame: Clinicians will report if blood leakage occurred immediately after the catheter insertion
Demonstrate superiority of the ViaValve™ Safety I.V. Catheter compared to the control in preventing blood leakage from the catheter hub during insertion.
Clinicians will report if blood leakage occurred immediately after the catheter insertion
Eliminating risk of blood exposure
Time Frame: Clinicians will report on the ability of the PIVC to eliminate blood exposure immediately after catheter insertion
Demonstrate superiority of the ViaValve™ Safety I.V. Catheter compared to the control PIVC in eliminating the clinician's risk of blood exposure during the insertion process.
Clinicians will report on the ability of the PIVC to eliminate blood exposure immediately after catheter insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insertion success
Time Frame: Clinicians will report if the insertion was successful immediately after performing insertion
Demonstrate the insertion success rate of the ViaValve™ I.V. Catheter is non-inferior to the control PIVC. Insertion success defined as a catheter confirmed successfully placed within the selected vessel in 3 or fewer venipuncture attempts.
Clinicians will report if the insertion was successful immediately after performing insertion
Elimination of digital compression
Time Frame: Clinicians will provide the rating immediately after performing the insertion
Demonstrate that the ViaValve™ Safety I.V. Catheter is non-inferior to the control PIVC in eliminating the clinician's need to use digital compression during the insertion process. Clinicians will agree or disagree the device eliminates the need for digital compression after each PIVC insertion.
Clinicians will provide the rating immediately after performing the insertion
Ease of Use
Time Frame: Clinicians will provide the rating immediately after performing the insertion
Demonstrate that the ViaValve™ Safety I.V. Catheter is non-inferior to the control PIVC in seven measures of ease of use. Clinicians will agree or disagree with seven statements regarding ease of use/clinical utility.
Clinicians will provide the rating immediately after performing the insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smiths Medical, ASD, Inc.

Investigators

  • Principal Investigator: Andrew McRae, MD, PhD, U of Calgary and Alberta Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

April 18, 2014

First Posted (ESTIMATE)

April 21, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 18, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ViaValve Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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