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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Participants who require a BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes as part of their routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who will receive a spinal anesthesia procedure as part of their routine medical care.
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Hoerauf, MD | Becton, Dickinson and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barmherzige Bruder Krankenhaus Salzburg | Salzburg | Austria | ||||
| Medizinische Universität Wien |
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In this post-market study, the choice of BD Spinal NRFit™ needle (gauge, length, tip type), BD Syringes NRFit™, BD Spinal NRFit™ needle set, and BD Spinal Introducer NRFit™ needle was at clinician discretion. A total of 161 subjects were enrolled to ensure a minimum of 150 received spinal anesthesia and were observed for 10 days post-procedure for adverse events/complications. A minimum of 50 subjects per tip type (Quincke and Whitacre) were included.
The study was conducted at 5 sites in 3 European countries. The first participant was enrolled on July 24, 2023 and the last participant had the last study visit on June 07,2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants who require a BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes as part of their routine medical care. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants in whom a spinal anesthesia procedure is attempted, regardless of success.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treated Population | Participants who underwent a neuraxial procedure, regardless of success. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants in whom a spinal anesthesia procedure is attempted, regardless of success. | Posted | Count of Participants | Participants | During insertion procedure |
|
From the spinal anesthesia up to 10 days (± 3 days) post procedure
An Adverse Event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users, or other persons, whether or not related to the investigational medical devices or procedure and whether anticipated or unanticipated. Please refer to ISO 14155:2020 for serious adverse event definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Population | All participants in whom a spinal anesthesia procedure is successful |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoaesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment | One SAE occurred in 1 of 153 subjects undergoing a neuraxial procedure. Due to prolonged hypesthesia possibly related to the spinal procedure, surgery could not be performed outpatient, requiring overnight hospitalization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gloria Viti/Clinical Project Manager | Becton, Dickinson and Company | 00393452237718 | gloria.viti@bd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 10, 2023 | Nov 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2024 | Dec 2, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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 |
| Vienna |
| Austria |
| Charité Campus Benjamin Franklin | Berlin | Germany |
| Universitätsklinikum Leipzig | Leipzig | Germany |
| Hospital Universitario Quirónsalud Madrid | Madrid | Spain |
| Adverse Event |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | Kg |
|
| Reasons for Surgery | Count of Participants | Participants |
|
| Reason for Neuraxial Procedure: Anesthesia | Count of Participants | Participants |
|
| American Society of Anesthesiologists (ASA) Physical Status (PS) Classification | The physician was responsible for assigning participants according to the ASA Physical Status classification:
For a complete description, please refer to the study protocol. | Count of Participants | Participants |
|
| Participant position during spinal anesthesia | Count of Participants | Participants |
|
| Aseptic Technique | Count of Participants | Participants |
|
| Local Anaesthesia | Count of Participants | Participants |
|
| Number of Puncture Attempts | Count of Participants | Participants |
|
| Lumbar interspace | Count of Participants | Participants |
|
| Device Used | Count of Participants | Participants |
|
| BD Spinal NRFit™ Needle Type | Count of Participants | Participants |
|
| Spontaneous appearance of CSF emerging from the needle hub | Number of participants with a successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid (CSF) from the spinal needle hub | Count of Participants | Participants |
|
| BD NRFit™ Syringe Usage | Count of Participants | Participants |
|
| Ancillary device Usage | Count of Participants | Participants |
|
| Anesthetic medication aspiration | Count of Participants | Participants |
|
| Anesthetic medication successfully aspirated using the BD NRFit™ syringe | Count of Participants | Participants |
|
| Anesthetic medication injection through BD NRFit™ syringe | Count of Participants | Participants |
|
|
|
| Primary | 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. | All participants in whom a spinal anesthesia procedure is attempted using a BD NRFit™ Spinal Introducer, regardless of success. | Posted | Count of Participants | Participants | During insertion procedure |
|
|
|
| Primary | 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. | All participants in whom a spinal anesthesia procedure is attempted, regardless of success | Posted | Count of Participants | Participants | During insertion procedure |
|
|
|
| Primary | 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. | All participants in whom a spinal anesthesia procedure is successful | Posted | Count of Participants | Participants | During insertion procedure |
|
|
|
| Primary | 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. | All participants in whom a spinal anesthesia procedure is successful | Posted | Count of Participants | Participants | From insertion up to 10 (± 3 days) post procedure |
|
|
|
| Primary | Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events | Percentage of participants with any device/procedure-related adverse events. | All participants in whom a spinal anesthesia procedure is attempted, regardless of success | Posted | Count of Participants | Participants | From insertion up to 10 (± 3 days) post procedure |
|
|
|
| Primary | 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. | All participants in whom a spinal anesthesia procedure is successful | Posted | Count of Participants | Participants | During the insertion procedure |
|
|
|
| 0 |
| 153 |
| 1 |
| 153 |
| 14 |
| 153 |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Rate of post dural puncture headache (PDPH) |
|
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| Rate of participants with any procedure-related adverse events (other than PDPH) |
|
| Rate of participants with any BD NRFit™spinal needle, introducer, syringe, or procedure-related AEs |
|