Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories.

Anesthesia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05953363
• Other study ID #: MDS-21NRFit001
• Status: Recruiting
• Start date: July 24, 2023
• Est. completion date: August 3, 2024

Study information

• Verified date: February 2024
• Source: Becton, Dickinson and Company
• Contact: Gloria Viti
• Phone: +39 3452237718
• Email: gloria.viti[@]bd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 3, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Austria	Barmherzige Bruder Krankenhaus Salzburg	Salzburg
Austria	Medizinische Universität Wien	Wien
Germany	Charité Campus Benjamin Franklin	Berlin
Germany	Universitätsklinikum Leipzig	Leipzig
Spain	Hospital Universitario Quirónsalud Madrid	Madrid
Spain	Hospital Universitario del Río Hortega	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Countries where clinical trial is conducted

Austria,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Primary Performance	Percentage of participants with successful aspiration and injection of anesthetic through a BD NRFit™ Syringe.	During insertion procedure
Primary	Primary Performance	Percentage of participants with BD NRFit™ Syringes that do not leak at the connection point during medication administration.	During insertion procedure
Primary	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	Primary Safety	Incidence of device/procedure-related adverse events.	From insertion up to 10 (± 3 days) post procedure