NCT06632509

BD SiteRite(TM) 9 Ultrasound System - Clinical Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 149 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This post-market study is being conducted to generate safety and performance data on the SiteRite 9 System. The data will be utilized to support regional registrations (for example, EU MDR), and document any unforeseen residual risks.

Detailed description

This is an observational post-market, human subject study to evaluate the safety and performance of the SiteRite 9 System. Subjects will be recruited for participation based on need for Vascular Access Device (VAD) placement in a hospital setting. Enrolled subjects will go through ultrasound-guided Vascular Access Device (USGVAD) placement as part of their clinical care. USGVAD is defined as a procedure in which an ultrasound machine is used to assist a qualified health care provider with IV cannulation from skin puncture through venipuncture via direct visualization on the ultrasound machine in real time.

Conditions

• BD SiteRite 9 for VAD Insertion

Interventions

Type	Name	Description
DEVICE	BD SiteRite(TM) 9	Ultrasound-guided vascular access device placement procedure using the BD SiteRite(TM) 9.

Timeline

• Start date: 2025-11-12
• Primary completion: 2026-01-09
• Completion: 2026-01-09
• First posted: 2024-10-09
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States