NCT04841330

Prospective Healthy Volunteer Study of the Securis™ Stabilization Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 104 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to assess the performance of the Securis™ Stabilization Device in simulated clinical use.

Detailed description

This study is designed to collect prospective observational data related to the safety and performance of the Securis™ Stabilization Device in healthy volunteers utilizing a simulated use method. Participants will have an intravenous catheter applied (not inserted) onto their forearm with a Securis™ 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.

Conditions

• Peripheral Intavenous Catheter Stabilization

Interventions

Type	Name	Description
DEVICE	Securis™ Stabilization Device	A trained clinician will apply and remove, and participants will wear the Securis™ Stabilization Device for up to one week (7 days) on their forearm. A shortened catheter will be placed (not inserted) over the Securis™ 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.

Timeline

• Start date: 2021-06-09
• Primary completion: 2021-07-20
• Completion: 2021-07-20
• First posted: 2021-04-12
• Last updated: 2021-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study