Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories.

Completed

• Conditions: Anesthesia; Analgesia
• Interventions: Device: BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes

• Registration Number: NCT05953363
• Lead Sponsor: Becton, Dickinson and Company

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.

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 Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-20
• Study Start: 2023-07-24
• Status Verified: 2024-02
• Primary Completion: 2024-05-28
• Study Completion: 2024-06-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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).

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes	Participants who require a BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes as part of their routine medical care.

Primary Outcome Measures

Name	Time	Method
Primary Safety	From insertion up to 10 (± 3 days) post procedure	Incidence of device/procedure-related adverse events.
Primary Performance	During insertion procedure	Percentage of participants with BD NRFit™ Syringes that do not leak at the connection point during medication administration.

Trial Locations

Locations (5)

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Medizinische Universität Wien; 🇦🇹 Wien, Austria

Barmherzige Bruder Krankenhaus Salzburg; 🇦🇹 Salzburg, Austria

Hospital Universitario Quirónsalud Madrid; 🇪🇸 Madrid, Spain

Charité Campus Benjamin Franklin; 🇩🇪 Berlin, Germany