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This study is being conducted to assess the performance of the Securisâ„¢ Stabilization Device in simulated clinical use.
This study is designed to collect prospective observational data related to the safety and performance of the Securisâ„¢ Stabilization Device in healthy volunteers utilizing a simulated use method. Participants will have an intravenous catheter applied (not inserted) onto their forearm with a Securisâ„¢ Stabilization Device applied over it. The site/device will be assessed over a period of 9 days (ideally Days 0-7 in-clinic and Day 8 virtually). The assessments will include the appearance of the site, the appearance of the dressing, and the movement of the catheter tip under the dressing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | A minimum of 100 healthy volunteer participants (14yo and older) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Securisâ„¢ Stabilization Device | Device | A trained clinician will apply and remove, and participants will wear the Securisâ„¢ Stabilization Device for up to one week (7 days) on their forearm. A shortened catheter will be placed (not inserted) over the Securisâ„¢ device in accordance with the product Information for Use (IFU), and an extension set attached to the catheter and secured in place, to simulate clinical use. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Securisâ„¢ Stabilization Device Securement Failure During Simulated Use | Device securement failure is defined as any of the following:
| From time of placement and up to 8 days after removal |
| Percentage of Participants with Select Skin Conditions Observed During Securisâ„¢ Stabilization Device Use | Select skin conditions include any of the following:
| From placement and up tp to 24 hours after device removal |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Securisâ„¢ Stabilization Device-related Adverse Events | Rate of device-related adverse events calculated as the number of participants with adverse events related to the device divided by the total number of evaluable participants. | From placement and up to 24 hours after device removal |
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Inclusion Criteria:
Exclusion Criteria:
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Potential participants will be recruited from healthy volunteer participant pools identified and/or held by the study site.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Casser, MD | TKL Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TKL Research, Inc | Fair Lawn | New Jersey | 07410 | United States |
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