CompletedNot Applicable

BD SiteRite(TM) 9 Ultrasound System - Clinical Study

United States149 participantsStarted 2025-11-12

Plain-language 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.

Who can participate

Age range

1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: During the procedure

Primary Performance: To have successful vascular access either by cannulation or blood return.

Timeframe: 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.

Timeframe: During the procedure and 15 minutes after the procedure

Trial details

NCT IDNCT06632509

SponsorBecton, Dickinson and Company

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-01-09

View on ClinicalTrials.gov More BD SiteRite 9 for VAD Insertion trials

Who can participate

Age range

1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: During the procedure

Primary Performance: To have successful vascular access either by cannulation or blood return.

Timeframe: 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.

Timeframe: During the procedure and 15 minutes after the procedure