BD SiteRite(TM) 9 Ultrasound System - Clinical Study

Not yet recruiting

• Conditions: BD SiteRite 9 for VAD Insertion
• Interventions: Device: BD SiteRite(TM) 9

• Registration Number: NCT06632509
• Lead Sponsor: Becton, Dickinson and Company

Brief 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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-09
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Study Start: 2025-01
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

Not provided

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Exclusion Criteria

• Any patient in whom ultrasound procedure might interfere with medical care or create undue hardship
• Known, or suspected, allergy to materials contained in the SiteRite 9 System or accessories that may come in contact with the patient
• Localized skin, tissue, or other clinical factors that would prevent completion of the ultrasound procedure
• Previous medical history that would prevent completion of the ultrasound procedure

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
USGVAD	BD SiteRite(TM) 9	Patient who is a candidate for an ultrasound-guided vascular access device (USGVAD) placement procedure using SiteRite 9 System as assessed per their clinician(s)

Primary Outcome Measures

Name	Time	Method
Primary Performance: To provide visualization of the target vessel in which to insert the chosen vascular access device.	During the procedure	The BD SiteRiteTM 9 Ultrasound System is able to visualize the target vasculature (\>=70% with a 95% confidence interval)
Primary Performance: To have successful vascular access either by cannulation or blood return.	During the procedure	Successful access with the vascular access device, either by cannulation or blood return (\>=70% with a 95% confidence interval)
Primary Safety: To determine the incidence of device related adverse events, experienced by patient or user, when using the BD SiteRiteTM 9 Ultrasound System.	During the procedure and 15 minutes after the procedure	Rate of device related adverse events (\<2%).