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

Peripheral Intravenous Catheter Clinical Trial

— ViaValve-001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119351
• Other study ID #: ViaValve Study
• Status: Completed
• Phase: N/A
• First received: July 12, 2013
• Last updated: April 18, 2014
• Start date: July 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: Smiths Medical, ASD, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Intravenous Catheter

Intervention

Device:
• ViaValve™ Safety IV Catheter
Safety peripheral IV catheter with a blood control feature
• ProtectIV® Plus Safety IV Catheter
Safety peripheral IV catheter with no blood control feature

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Smiths Medical, ASD, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Insertion success	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
Secondary	Elimination of digital compression	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
Secondary	Ease of Use	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