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

Study Overview
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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.

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

Conditions
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Peripheral Intravenous Catheter

Intervention / Treatment
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* Device: ViaValve™ Safety IV Catheter
* Device: ProtectIV® Plus Safety IV Catheter


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ViaValve™ Safety IV Catheter<br>Insertion of the ViaValve™ Safety IV Catheter | Device: ViaValve™ Safety IV Catheter<br>* Safety peripheral IV catheter with a blood control feature<br>|
| Active Comparator: ProtectIV® Plus Safety IV Catheter<br>Insertion of the ProtectIV® Plus Safety IV Catheter | Device: ProtectIV® Plus Safety IV Catheter<br>* Safety peripheral IV catheter with no blood control feature<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral intravenous catheters, blood exposure, blood control, IV catheter insertion