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

Smiths Medical

Status: Completed

Conditions: Peripheral Intravenous Catheter

Treatments: Device: ProtectIV® Plus Safety IV Catheter; Device: ViaValve™ Safety IV Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02119351

ViaValve Study

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

ViaValve™ Safety IV Catheter

Active Comparator group

Description:

Insertion of the ViaValve™ Safety IV Catheter

Treatment:

Device: ViaValve™ Safety IV Catheter

ProtectIV® Plus Safety IV Catheter

Active Comparator group

Description:

Insertion of the ProtectIV® Plus Safety IV Catheter

Treatment:

Device: ProtectIV® Plus Safety IV Catheter