NCT05953363

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 161 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Anesthesia
• Analgesia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-24
• Primary completion: 2024-05-28
• Completion: 2024-06-07
• First posted: 2023-07-20
• Last updated: 2025-12-19
• Results posted: 2025-12-19

Locations

5 sites across 3 countries: Austria, Germany, Spain