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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ViaValve™ Safety IV Catheter | Active Comparator | Insertion of the ViaValve™ Safety IV Catheter |
|
| ProtectIV® Plus Safety IV Catheter | Active Comparator | Insertion of the ProtectIV® Plus Safety IV Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViaValve™ Safety IV Catheter | Device | Safety peripheral IV catheter with a blood control feature |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew McRae, MD, PhD | U of Calgary and Alberta Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | Canada |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 18, 2015 | |
| Reset | Jun 3, 2015 | |
| Release | Apr 24, 2017 | |
| Reset | Aug 2, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 18, 2015 | Jun 3, 2015 | |||
| Apr 24, 2017 |
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| ProtectIV® Plus Safety IV Catheter | Device | Safety peripheral IV catheter with no blood control feature |
|
| 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 |
| Aug 2, 2017 |