N/A
Completed N=161
Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories.
Anesthesia · Analgesia
Source: ClinicalTrials.gov NCT05953363 ↗
Enrolled (actual)
161
Serious AEs
0.7%
Results posted
Dec 2025
Primary outcomePrimary: Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location — 100; 46; 146 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location |
100; 46; 146 | — |
| PRIMARY Primary Performance: Rate of of Participants With Successful Needle Placement in the Subarachnoid Location When a BD Spinal NRFit™ Introducer is Used |
124 | — |
| PRIMARY Primary Performance: Rate of Participants With Successful Aspiration Through BD NRFit™ Syringes |
153 | — |
| PRIMARY Primary Performance: Rate of Participants With BD NRFit™ Syringes That do Not Leak at the Connection Point During Medication Administration |
145 | — |
| PRIMARY Primary Safety: Rate of Participants With a Diagnosis of Post Dural Puncture Headache (PDPH) |
1; 2; 3 | — |
| PRIMARY Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events |
0; 0; 0; 6; 6 | — |
| PRIMARY Primary Performance: Rate of of Participants With Successful Injection of Anesthetic Through BD NRFit™ Syringes |
146 | — |
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05953363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.