A Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Intravenous Catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ViaValve™ Safety IV Catheter

Insertion of the ViaValve™ Safety IV Catheter

Group Type ACTIVE_COMPARATOR

ViaValve™ Safety IV Catheter

Intervention Type DEVICE

Safety peripheral IV catheter with a blood control feature

ProtectIV® Plus Safety IV Catheter

Insertion of the ProtectIV® Plus Safety IV Catheter

Group Type ACTIVE_COMPARATOR

ProtectIV® Plus Safety IV Catheter

Intervention Type DEVICE

Safety peripheral IV catheter with no blood control feature

Interventions

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ViaValve™ Safety IV Catheter

Safety peripheral IV catheter with a blood control feature

Intervention Type DEVICE

ProtectIV® Plus Safety IV Catheter

Safety peripheral IV catheter with no blood control feature

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No