Completed

NCT Number: NCT06632509

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.

Completed

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Key information

Conditions

BD SiteRite 9 for VAD Insertion

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brookdale University Hospital & Medical Center

Brooklyn, New York, 11212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BD SiteRite(TM) 9

Device

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

Primary outcomes

Primary Performance: To provide visualization of the target vessel in which to insert the chosen vascular access device.

Time frame: 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.

Time frame: 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.

Time frame: During the procedure and 15 minutes after the procedure

Rate of device related adverse events (<2%).

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Oct 9, 2024
Registry last updated: Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.