BD SiteRite(TM) 9 Ultrasound System - Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: BD SiteRite 9 for VAD Insertion
• Intervention / Treatment: Device: BD SiteRite(TM) 9

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 Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11212
      • Brookdale University Hospital & Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects are defined as patients who need to receive insertion of a vascular access devices (VAD) as part of their medical treatment.

Description

Inclusion Criteria

• Age 1 years, or older
• A patient who is a candidate for an ultrasound-guided VAD placement procedure using SiteRite 9 System as assessed per their clinician(s)
• Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the subject

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
USGVAD; 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)	Device: BD SiteRite(TM) 9; Ultrasound-guided vascular access device placement procedure using the BD SiteRite(TM) 9.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2025
• Primary Completion (Actual): January 9, 2026
• Study Completion (Actual): January 9, 2026

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MDS-23SITERITE001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No