BD SiteRite 9 for VAD InsertionNCT06632509
BD SiteRite(TM) 9 Ultrasound System - Clinical Study
An observational study of BD SiteRite 9 for VAD Insertion, run by Becton, Dickinson and Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- BD SiteRite 9 for VAD Insertion
- What is being tested?
- BD SiteRite(TM) 9
- Type of treatment
- Medical device
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2025to 9 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects are defined as patients who need to receive insertion of a vascular access devices (VAD) as part of their medical treatment.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brookdale University Hospital & Medical Center
Brooklyn, New York, 11212
About this 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.
Read the 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.
- Conditions
- BD SiteRite 9 for VAD Insertion
- Being tested
- BD SiteRite(TM) 9
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD SiteRite(TM) 9Device
Ultrasound-guided vascular access device placement procedure using the BD SiteRite(TM) 9.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: BD SiteRite(TM) 9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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%).
Measured: During the procedure and 15 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start12 Nov 2025
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BD SiteRite 9 for VAD InsertionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632509
- Sponsor's protocol ID
- MDS-23SITERITE001
- Status last verified
- Jan 2026
- First submitted
- 7 Oct 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BD SiteRite(TM) 9 Ultrasound System - Clinical Study
- ClinicalTrials.gov ID
- NCT06632509
- Acronym / sponsor ID
- MDS-23SITERITE001
- Conditions
- BD SiteRite 9 for VAD Insertion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| USGVAD | – | Device: BD SiteRite(TM) 9Patient who is a candidate for an ultrasound-guided vascular access device (USGVAD) placement procedure using SiteRite 9 System as assessed per their clinician(s) |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects are defined as patients who need to receive insertion of a vascular access devices (VAD) as part of their medical treatment.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD SiteRite(TM) 9Ultrasound-guided vascular access device placement procedure using the BD SiteRite(TM) 9. | Device | USGVAD |
Primary outcome
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%).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BD SiteRite 9 for VAD Insertion, run by Becton, Dickinson and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Performance: To provide visualization of the target vessel in which to insert the chosen vascular access device. (time frame: During the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.