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

NCT02119351 | Completed

• 1 other identifier: ViaValve Study
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Intravenous Catheter

Keywords

peripheral intravenous catheters; blood exposure; blood control; IV catheter insertion

Outcome Measures

Primary Outcomes (3)

• Clinical acceptability of PIVC 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

  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

  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 Outcomes (3)

• Insertion success

  Clinicians will report if the insertion was successful immediately after performing insertion

• Elimination of digital compression

  Clinicians will provide the rating immediately after performing the insertion

• Ease of Use

  Clinicians will provide the rating immediately after performing the insertion

Study Arms (2)

ViaValve™ Safety IV Catheter

ACTIVE COMPARATOR

Insertion of the ViaValve™ Safety IV Catheter

Device: ViaValve™ Safety IV Catheter

ProtectIV® Plus Safety IV Catheter

ACTIVE COMPARATOR

Insertion of the ProtectIV® Plus Safety IV Catheter

Device: ProtectIV® Plus Safety IV Catheter

Interventions

ViaValve™ Safety IV Catheter DEVICE

Safety peripheral IV catheter with a blood control feature

ViaValve™ Safety IV Catheter

ProtectIV® Plus Safety IV Catheter DEVICE

Safety peripheral IV catheter with no blood control feature

ProtectIV® Plus Safety IV Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Smiths Medical, ASD, Inc.: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Study Officials

• Andrew McRae, MD, PhD

  U of Calgary and Alberta Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: April 21, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

CA (1)