Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All participants Participants who require a BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes as part of their routine medical care. |
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.
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Outcome Measures
Primary Outcome Measures
- Primary Performance [During insertion procedure]
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.
- Primary Performance [During insertion procedure]
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.
- Primary Performance [During insertion procedure]
Percentage of participants with successful aspiration and injection of anesthetic through a BD NRFit™ Syringe.
- Primary Performance [During insertion procedure]
Percentage of participants with BD NRFit™ Syringes that do not leak at the connection point during medication administration.
- Primary Safety [From insertion up to 10 (± 3 days) post procedure]
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.
- Primary Safety [From insertion up to 10 (± 3 days) post procedure]
Incidence of device/procedure-related adverse events.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Expected to be available for observation through the study period (10 days, ± 3 days, post procedure*).
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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:
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Coagulopathy or bleeding disorder, where it is in the opinion of the investigator makes regional anesthetic of increased risk.
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Subjects with a history of neurological impairment of the trunk or lower extremities.
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Infection at the site of needle insertion.
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Previous spine surgery at the level involved in the study procedure. -
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Barmherzige Bruder Krankenhaus Salzburg | Salzburg | Austria | ||
| 2 | Medizinische Universität Wien | Wien | Austria | ||
| 3 | Charité Campus Benjamin Franklin | Berlin | Germany | ||
| 4 | Universitätsklinikum Leipzig | Leipzig | Germany | ||
| 5 | Hospital Universitario Quirónsalud Madrid | Madrid | Spain | ||
| 6 | Hospital Universitario del Río Hortega | Valladolid | Spain |
Sponsors and Collaborators
- Becton, Dickinson and Company
Investigators
- Study Director: Klaus Hoerauf, MD, Becton, Dickinson and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDS-21NRFit001