BD SiteRite(TM) 9 Ultrasound System - Clinical Study

NCT ID: NCT06632509

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-12

Study Completion Date

2026-01-09

Brief Summary

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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

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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

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BD SiteRite 9 for VAD Insertion

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

BD SiteRite(TM) 9

Intervention Type DEVICE

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

Interventions

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BD SiteRite(TM) 9

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Becton, Dickinson and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Brookdale University Hospital & Medical Center

Brooklyn, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MDS-23SITERITE001

Identifier Type: -

Identifier Source: org_study_id

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