BD SiteRite(TM) 9 Ultrasound System - Clinical Study

Becton, Dickinson and Company (BD)

Status: Begins enrollment in 1 month

Conditions: BD SiteRite 9 for VAD Insertion

Treatments: Device: BD SiteRite(TM) 9

Study type: Observational

Funder types: Industry

Identifiers

NCT06632509

MDS-23SITERITE001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

149 participants in 1 patient group

USGVAD

Description:

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)

Treatment:

Device: BD SiteRite(TM) 9