BD SiteRite(TM) 9 Ultrasound System - Clinical Study

NCT06632509 | Completed

• 1 other identifier: MDS-23SITERITE001
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

BD SiteRite 9 for VAD Insertion

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

BD SiteRite(TM) 9 DEVICE

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

USGVAD

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (1)

Brookdale University Hospital & Medical Center

Brooklyn, New York, 11212, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: November 12, 2025
• Primary Completion: January 9, 2026
• Study Completion: January 9, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)