Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories.

NCT05953363 | Completed Results

• 1 other identifier: MDS-21NRFit001
• Study Type: observational
• Target: 161
• Locations: 3 countries
• Sites: 5

Brief Summary

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.

Conditions

Anesthesia; Analgesia

Outcome Measures

Primary Outcomes (7)

• Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location

  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: Rate of of Participants With Successful Needle Placement in the Subarachnoid Location When a BD Spinal NRFit™ Introducer is Used

  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: Rate of Participants With Successful Aspiration Through BD NRFit™ Syringes

  Percentage of participants with successful aspiration of anesthetic through a BD NRFit™ Syringe.

  During insertion procedure

• Primary Performance: Rate of Participants With BD NRFit™ Syringes That do Not Leak at the Connection Point During Medication Administration

  Percentage of participants with BD NRFit™ Syringes that do not leak at the connection point during medication administration.

  During insertion procedure

• Primary Safety: Rate of Participants With a Diagnosis of Post Dural Puncture Headache (PDPH)

  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: Percentage of Participants With Any Study Device and Procedure Adverse Events

  Percentage of participants with any device/procedure-related adverse events.

  From insertion up to 10 (± 3 days) post procedure

• Primary Performance: Rate of of Participants With Successful Injection of Anesthetic Through BD NRFit™ Syringes

  Percentage of participants with successful injection of anesthetic through a BD NRFit™ Syringe.

  During the insertion procedure

Study Arms (1)

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

Interventions

BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes DEVICE

Insertion of a BD NRFit™ spinal needle and optional BD NRFit™ Spinal Introducer Needle using a BD NRFit™ Syringe to perform the neuraxial procedure.

All participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• Expected to be available for observation through the study period (10 days, ± 3 days, post procedure\*).
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (5)

Barmherzige Bruder Krankenhaus Salzburg

Salzburg, Austria

Location

Medizinische Universität Wien

Vienna, Austria

Location

Charité Campus Benjamin Franklin

Berlin, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Hospital Universitario Quirónsalud Madrid

Madrid, Spain

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gloria Viti/Clinical Project Manager
• Organization: Becton, Dickinson and Company

gloria.viti@bd.com

00393452237718

Study Officials

• Klaus Hoerauf, MD

  Becton, Dickinson and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: July 24, 2023
• Primary Completion: May 28, 2024
• Study Completion: June 7, 2024
• Last Updated: December 19, 2025
• Results First Posted: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); ES (1); AU (2)