Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories.

Multi-center, Prospective, Open Label, Single Arm Post-market Study of BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes on Participants Who Are Receiving Neuraxial Procedure.

Multi-center, prospective, open label, single arm post-market study to assess the real-world safety and efficacy of BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes used in an on-market fashion.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Anesthesia
• Intervention / Treatment: Device: BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes

Detailed Description

This is a multi-center, prospective, open label, single arm post-market study that will enroll approximately 180 participants in order to have a minimum of 150 treated participants who will receive a spinal anesthesia procedure as part of their routine medical care. Participants will be followed from the time of enrollment for up to 10 days (± 3 days) post spinal anesthesia procedure for evidence of adverse events including Post Dural Puncture Headache (PDPH). This can be done via phone if the participant is discharged from the hospital. The site staff must take advantage of the time window of ± 3 days only when the 10-day post-procedure occurs during the weekends or holidays. Any adverse event or complication must be diagnosed and confirmed by a study physician.

A minimum of 50 participants for each of the two needle tip types (Quincke and Whitacre tip) will be enrolled in the study.

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Gloria Viti; Phone Number: +39 3452237718; Email: gloria.viti@bd.com
• Study Contact Backup: Name: Winfried Huesmann; Phone Number: +49 15154403197; Email: winfried.huesmann@bd.com

Study Locations

• Austria
  • Salzburg, Austria
    • Recruiting
    • Barmherzige Bruder Krankenhaus Salzburg
    • Contact: Peter Paal, Prof.Dr.
    • Principal Investigator: Peter Paal, Prof.Dr.
  • Wien, Austria
    • Recruiting
    • Medizinische Universitat Wien
    • Contact: Oliver Kimberger, Prof. Dr.
    • Principal Investigator: Oliver Kimberger, Prof. Dr.
• Germany
  • Berlin, Germany
    • Recruiting
    • Charite Campus Benjamin Franklin
    • Contact: Sascha Treskatsch, Prof.Dr.
    • Principal Investigator: Sascha Treskatsch, Prof.Dr.
  • Leipzig, Germany
    • Recruiting
    • Universitätsklinikum Leipzig
    • Contact: Robert Werdehausen, Prof.Dr.
    • Principal Investigator: Robert Werdehausen, Prof.Dr.
• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario Quirónsalud Madrid
    • Contact: Jose Maria Marzal Barò, Dr.
    • Principal Investigator: Jose Maria Marzal Barò, Dr.
  • Valladolid, Spain
    • Not yet recruiting
    • Hospital Universitario del Río Hortega
    • Contact: César Aldecoa, Dr.
    • Principal Investigator: César Aldecoa, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who will receive a spinal anesthesia procedure as part of their routine medical care.

Description

Inclusion Criteria:

1. Any patient, regardless of age or gender, for which the investigator has decided that a neuraxial procedure must be performed utilizing BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes as part of their routine medical care.
2. Expected to be available for observation through the study period (10 days, ± 3 days, post procedure*).
3. Able and willing to provide signed and dated informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant (Note: Consent of guardian or parent may be required for participants under the age of 18 years; participant assent may be required as well).

Exclusion Criteria:

1. Coagulopathy or bleeding disorder, where it is in the opinion of the investigator makes regional anesthetic of increased risk.
2. Subjects with a history of neurological impairment of the trunk or lower extremities.
3. Infection at the site of needle insertion.
4. Previous spine surgery at the level involved in the study procedure.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants; Participants who require a BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes as part of their routine medical care.	Device: BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes; Insertion of a BD NRFit™ spinal needle and optional BD NRFit™ Spinal Introducer Needle using a BD NRFit™ Syringe to perform the neuraxial procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Performance	Percentage of participants with successful placement of the BD Spinal NRFit™ needle in the subarachnoid location defined as the spontaneous appearance of cerebrospinal fluid (CSF) emerging from the spinal needle hub.	During insertion procedure
Primary Performance	Percentage of participants with successful placement of the BD Spinal NRFit™ needle in the subarachnoid location defined as the spontaneous appearance of cerebrospinal fluid (CSF) emerging from the spinal needle hub when an BD NRFit™ introducer is used.	During insertion procedure
Primary Performance	Percentage of participants with successful aspiration and injection of anesthetic through a BD NRFit™ Syringe.	During insertion procedure
Primary Performance	Percentage of participants with BD NRFit™ Syringes that do not leak at the connection point during medication administration.	During insertion procedure
Primary Safety	Percentage of participants with a diagnosis of PDPH (defined as headache that worsens when standing/upright position and relieves when laying supine) for a period of up to 10 (± 3 days) days following the procedure.	From insertion up to 10 (± 3 days) post procedure
Primary Safety	Incidence of device/procedure-related adverse events.	From insertion up to 10 (± 3 days) post procedure

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Investigators: Study Director: Klaus Hoerauf, MD, Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): August 3, 2024

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MDS-21NRFit001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No