A Single Arm, Open-label First In Human Study for Assessing the Safety and Performance of the EpiFinder in Subjects With Clinical Indication for Lumbar Epidural Steroids Injection (ESI)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety - Device Related Serious Adverse Events
研究概览
简要总结
The EpiFinder device, which is the investigational device in this study, is intended for use in epidural procedures, between a luer syringe and an epidural needle, to give the treating physician a clear indication that the needle tip has entered the epidural space. The objective of this First In Human study is to evaluate the safety and performance of using the EpiFinder to identify the epidural space in subjects with a clinical indication to receive a lumbar Epidural Steroid Injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years or older
- •Subject with clinical indication for lumbar ESI based on subject's clinical problem (e.g. DDD hernia disc, spinal stenosis)
- •Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
排除标准
- •Subject with marked spinal deformities
- •Previous back surgery
- •Contraindication for epidural injections (e.g. continuous use of anticoagulants, infection, allergic reactions to the injected substances)
- •Subject has known hypersensitivity to contrast media that cannot be pre-medicated
- •Subject with severe obesity (body mass index >35 kg/m2)
- •Subject observed seizure within 7 days prior to study enrollment
- •Subject presenting for emergency
- •Subject has a skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) in their lumbar region
- •Subject is pregnant (to be determined by urine pregnancy test)
- •Subject who is currently participating or has participated in an investigational study, within the past 30 days
结局指标
主要结局
Safety - Device Related Serious Adverse Events
时间窗: 14 days
cumulative incidence of device-related complications and Serious adverse events (AE), observed during the procedure and throughout the follow-up period. Device related adverse events include: dural puncture with or without headache, epidural hematoma, seizures, neurological deficit or relevant device complications. All related and non-related adverse events will be observed on a continuous basis from the baseline through the study completion.
次要结局
- Device Performance - Physician satisfaction(Procedure)
- Device Efficacy - Epidural Space Identification(Procedure)