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Investigational Study With the BD PosiFlush™ SafeScrub on NADs | Clinical Trials | Clareo Health

RECRUITINGNA

Investigational Study With the BD PosiFlush™ SafeScrub on NADs

An Investigational Study to Evaluate the Safety and Performance of the BD PosiFlush™ SafeScrub on Needleless Access Devices

NCT06604026•Becton, Dickinson and Company

View on ClinicalTrials.gov

Summary

This study is an investigational study to evaluate the safety and performance of the BD PosiFlush™ SafeScrub on needleless access devices.

Detailed Description

This study is being conducted to generate clinical data to support the performance and safety of BD PosiFlush™ SafeScrub. The study data will be used for regulatory submission in EU.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Any patient (≥18 years of age) in a high acuity hospital medical or surgical unit regardless of gender, with an eligible in-situ vascular access device and with a needleless access device (NAD). This includes patients who have a current VAD, whether it is newly placed or long-term access as part of their routine medical care. Eligible in-situ vascular access devices are peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs) and implanted venous access ports. Eligible NADs are stopcocks, Y-sites, and needle-free connectors.
•2. Expected to be available until 2 accesses are completed and for any periodic observation upto 15 min after each access.
•3. Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant.

Exclusion Criteria

•Any patient in whom observation might interfere with medical care or create undue hardship as determined by the patients care team.
•Patients under the age of 18.
•Patients suffering hypernatremia and fluid retention, when the administration of sodium or chloride could be clinically detrimental as determined by the study investigator.
•Patients with a known allergy to any of the followings as determined by the study investigator:
•Any of the components or materials of BD PosiFlush™ SafeScrub device or BD PosiFlush™ SP Syringe, or
•0.9% sodium chloride solution
•Pregnant or breastfeeding women
•Urine pregnancy test will be required for all women of childbearing age who want to participate in the study

Locations (2)

Ordensklinikum Linz Elisabethinen

Linz, Upper Austria, Austria

Medical University Vienna

Vienna, Austria

Key Dates

Start Date

October 22, 2024

Primary Completion Date

February 28, 2026

Completion Date

February 28, 2026

Last Updated

February 17, 2026

Enrollment

220

ESTIMATED participants

Conditions

CRBSI - Catheter Related Bloodstream Infection

Interventions

BD PosiFlush™ SafeScrub

DEVICE

BD PosiFlush™

DEVICE

Contacts

Sabine Riedl

CONTACT

+491715550267 sabine.riedl@bd.com

Christophe Van Laethem

CONTACT

0477779202 Christophe.Van.Laethem@bd.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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