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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 5
- 主要终点
- Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Expected to be available for observation through the study period (10 days, ± 3 days, post procedure*).
- •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).
排除标准
- •Coagulopathy or bleeding disorder, where it is in the opinion of the investigator makes regional anesthetic of increased risk.
- •Subjects with a history of neurological impairment of the trunk or lower extremities.
- •Infection at the site of needle insertion.
- •Previous spine surgery at the level involved in the study procedure.
结局指标
主要结局
Primary Safety: Percentage of Participants With Any Study Device and Procedure Adverse Events
时间窗: From insertion up to 10 (± 3 days) post procedure
Percentage of participants with any device/procedure-related adverse events.
Primary Performance: Rate of Participants With Successful BD Spinal NRFit™ Needle Placement in the Subarachnoid Location
时间窗: 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: Rate of of Participants With Successful Needle Placement in the Subarachnoid Location When a BD Spinal NRFit™ Introducer is Used
时间窗: 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: Rate of Participants With Successful Aspiration Through BD NRFit™ Syringes
时间窗: During insertion procedure
Percentage of participants with successful aspiration of anesthetic through a BD NRFit™ Syringe.
Primary Performance: Rate of Participants With BD NRFit™ Syringes That do Not Leak at the Connection Point During Medication Administration
时间窗: During insertion procedure
Percentage of participants with BD NRFit™ Syringes that do not leak at the connection point during medication administration.
Primary Safety: Rate of Participants With a Diagnosis of Post Dural Puncture Headache (PDPH)
时间窗: 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 Performance: Rate of of Participants With Successful Injection of Anesthetic Through BD NRFit™ Syringes
时间窗: During the insertion procedure
Percentage of participants with successful injection of anesthetic through a BD NRFit™ Syringe.
次要结局
未报告次要终点