Trial Outcomes & Findings for Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories. (NCT NCT05953363)

Last Updated: 2025-12-19

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

161 participants

Primary outcome timeframe

During insertion procedure

Results posted on

2025-12-19

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	161
Overall Study Enrolled Population	161
Overall Study Treated Population	153
Overall Study Safety Population	146
Overall Study COMPLETED	153
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Screen Failure	2
Overall Study Withdrawal by Subject	3
Overall Study Surgery cancelled	2
Overall Study Adverse Event	1

Baseline Characteristics

Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treated Population n=153 Participants Participants who underwent a neuraxial procedure, regardless of success.
Age, Continuous	63.0 years STANDARD_DEVIATION 17.28 • n=8 Participants
Sex: Female, Male Female	58 Participants n=8 Participants
Sex: Female, Male Male	95 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=8 Participants
Race (NIH/OMB) White	149 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=8 Participants
Region of Enrollment Austria	59 participants n=8 Participants
Region of Enrollment Germany	49 participants n=8 Participants
Region of Enrollment Spain	45 participants n=8 Participants
Height	172.3 cm STANDARD_DEVIATION 9.47 • n=8 Participants
Weight	80.76 Kg STANDARD_DEVIATION 18.753 • n=8 Participants
Reasons for Surgery Surgery of Lower Extremities	91 Participants n=8 Participants
Reasons for Surgery Surgery of Lower Abdomen	40 Participants n=8 Participants
Reasons for Surgery Surgery of Perineum	4 Participants n=8 Participants
Reasons for Surgery Surgery of Hips and Pelvis	18 Participants n=8 Participants
Reason for Neuraxial Procedure: Anesthesia	153 Participants n=8 Participants
American Society of Anesthesiologists (ASA) Physical Status (PS) Classification I	31 Participants n=8 Participants
American Society of Anesthesiologists (ASA) Physical Status (PS) Classification II	94 Participants n=8 Participants
American Society of Anesthesiologists (ASA) Physical Status (PS) Classification III	28 Participants n=8 Participants
Participant position during spinal anesthesia Lateral	6 Participants n=8 Participants
Participant position during spinal anesthesia Sitting	147 Participants n=8 Participants
Aseptic Technique Chlorohexidine	43 Participants n=8 Participants
Aseptic Technique Betadine	10 Participants n=8 Participants
Aseptic Technique Octenidine	32 Participants n=8 Participants
Aseptic Technique Other	68 Participants n=8 Participants
Local Anaesthesia Lidocaine 1%	113 Participants n=8 Participants
Local Anaesthesia Lidocaine 2%	35 Participants n=8 Participants
Local Anaesthesia Other	5 Participants n=8 Participants
Number of Puncture Attempts 1	142 Participants n=8 Participants
Number of Puncture Attempts 2	10 Participants n=8 Participants
Number of Puncture Attempts 3	1 Participants n=8 Participants
Lumbar interspace L2-3	12 Participants n=8 Participants
Lumbar interspace L3-4	94 Participants n=8 Participants
Lumbar interspace L4-5	44 Participants n=8 Participants
Lumbar interspace Other	3 Participants n=8 Participants
Device Used BD Spinal NRFit™ Needle Set	128 Participants n=8 Participants
Device Used BD Spinal NRFit™ Needle	25 Participants n=8 Participants
BD Spinal NRFit™ Needle Type BD Spinal NRFit™ Whitacre Needle	103 Participants n=8 Participants
BD Spinal NRFit™ Needle Type BD Spinal NRFit™ Quincke Needle	50 Participants n=8 Participants
Spontaneous appearance of CSF emerging from the needle hub Spontaneous appearance of CSF emerging from the needle hub	146 Participants n=8 Participants
Spontaneous appearance of CSF emerging from the needle hub No spontaneous appearance of CSF emerging from the needle hub	7 Participants n=8 Participants
BD NRFit™ Syringe Usage BD Syringes NRFit™ Lok with a volume of 3 mL	7 Participants n=8 Participants
BD NRFit™ Syringe Usage BD Syringes NRFit™ Slip with a volume of 5 mL	146 Participants n=8 Participants
Ancillary device Usage BD Blunt Fill NRFit™ Needle	79 Participants n=8 Participants
Ancillary device Usage BD Blunt Filter NRFit™ Needle	74 Participants n=8 Participants
Anesthetic medication aspiration Anesthetic medication aspirated from vial	43 Participants n=8 Participants
Anesthetic medication aspiration Anesthetic medication aspirated from ampule	110 Participants n=8 Participants
Anesthetic medication successfully aspirated using the BD NRFit™ syringe	153 Participants n=8 Participants
Anesthetic medication injection through BD NRFit™ syringe Anesthetic medication successfully injected through BD NRFit™ syringe	146 Participants n=8 Participants
Anesthetic medication injection through BD NRFit™ syringe No anesthetic medication successfully injected through BD NRFit™ syringe	7 Participants n=8 Participants

PRIMARY outcome

Timeframe: During insertion procedure

Population: All participants in whom a spinal anesthesia procedure is attempted, regardless of success.

Outcome measures

Outcome measures
Measure	All Participants n=153 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.
Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location Rate of successful placement of BD Spinal NRFit™ Whitacre Needle in subarachnoid location	100 Participants
Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location Rate of successful BD Spinal NRFit™ Quincke Needle placement in subarachnoid location	46 Participants
Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location Rate of successful BD Spinal NRFit™ Needle placement in subarachnoid location	146 Participants

PRIMARY outcome

Timeframe: During insertion procedure

Population: All participants in whom a spinal anesthesia procedure is attempted using a BD NRFit™ Spinal Introducer, regardless of success.

Outcome measures

Outcome measures
Measure	All Participants n=130 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.
Primary Performance: Rate of of Participants With Successful Needle Placement in the Subarachnoid Location When a BD Spinal NRFit™ Introducer is Used	124 Participants

PRIMARY outcome

Timeframe: During insertion procedure

Population: All participants in whom a spinal anesthesia procedure is attempted, regardless of success

Percentage of participants with successful aspiration of anesthetic through a BD NRFit™ Syringe.

Outcome measures

Outcome measures
Measure	All Participants n=153 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.
Primary Performance: Rate of Participants With Successful Aspiration Through BD NRFit™ Syringes	153 Participants

PRIMARY outcome

Timeframe: During insertion procedure

Population: All participants in whom a spinal anesthesia procedure is successful

Percentage of participants with BD NRFit™ Syringes that do not leak at the connection point during medication administration.

Outcome measures

Outcome measures
Measure	All Participants n=146 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.
Primary Performance: Rate of Participants With BD NRFit™ Syringes That do Not Leak at the Connection Point During Medication Administration	145 Participants

PRIMARY outcome

Timeframe: From insertion up to 10 (± 3 days) post procedure

Population: All participants in whom a spinal anesthesia procedure is successful

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.

Outcome measures

Outcome measures
Measure	All Participants n=146 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.
Primary Safety: Rate of Participants With a Diagnosis of Post Dural Puncture Headache (PDPH) Rate of post dural puncture headache (PDPH) for Subjects Using Whitacre Needle	1 Participants
Primary Safety: Rate of Participants With a Diagnosis of Post Dural Puncture Headache (PDPH) Rate of post dural puncture headache (PDPH) for Subjects Using Quincke Needle	2 Participants
Primary Safety: Rate of Participants With a Diagnosis of Post Dural Puncture Headache (PDPH) Rate of post dural puncture headache (PDPH)	3 Participants

PRIMARY outcome

Timeframe: From insertion up to 10 (± 3 days) post procedure

Population: All participants in whom a spinal anesthesia procedure is attempted, regardless of success

Percentage of participants with any device/procedure-related adverse events.

Outcome measures

Outcome measures
Measure	All Participants n=153 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.
Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events Rate of participants with any BD NRFit™spinal needle, introducer, syringe, or procedure-related AEs	6 Participants
Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events Rate of participants with any procedure-related adverse events (other than PDPH)	6 Participants
Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events Rate of participants with any BD NRFit™ spinal needle related adverse events (other than PDPH)	0 Participants
Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events Rate of participants with any BD NRFit™ introducer-related adverse events (other than PDPH)	0 Participants
Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events Rate of participants with any BD NRFit™ syringe-related adverse events (other than PDPH)	0 Participants

PRIMARY outcome

Timeframe: During the insertion procedure

Population: All participants in whom a spinal anesthesia procedure is successful

Percentage of participants with successful injection of anesthetic through a BD NRFit™ Syringe.

Outcome measures

Outcome measures
Measure	All Participants n=146 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.
Primary Performance: Rate of of Participants With Successful Injection of Anesthetic Through BD NRFit™ Syringes	146 Participants

Adverse Events

Safety Population

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Safety Population n=153 participants at risk All participants in whom a spinal anesthesia procedure is successful
Nervous system disorders Hypoaesthesia	0.65% 1/153 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Safety Population n=153 participants at risk All participants in whom a spinal anesthesia procedure is successful
Ear and labyrinth disorders Vertigo	0.65% 1/153 • 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.
Gastrointestinal disorders Nausea	1.3% 2/153 • 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.
Infections and infestations Urinary tract infection	0.65% 1/153 • 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.
Injury, poisoning and procedural complications Procedural headache	2.0% 3/153 • 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.
Injury, poisoning and procedural complications Urinary retention postoperative	0.65% 1/153 • 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.
Musculoskeletal and connective tissue disorders Back pain	0.65% 1/153 • 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.
Nervous system disorders Headache	2.6% 4/153 • 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.
Nervous system disorders Presyncope	0.65% 1/153 • 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.
Renal and urinary disorders Urinary retention	0.65% 1/153 • 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.
Vascular disorders Haemorrhage	0.65% 1/153 • 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.
Vascular disorders Hypotension	0.65% 1/153 • 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.

Additional Information

Gloria Viti/Clinical Project Manager

Becton, Dickinson and Company

Phone: 00393452237718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place