NCT03105882撤回不适用
Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal Scaffold for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5 - T1 Neurological Levels
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Incidence of all Adverse Device Effects of any kind/seriousness.
研究概览
简要总结
Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal ScaffoldTM for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5-T1 Neurological Levels The purpose of this study is to support an expansion to support marketing applications as well as future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16-70 years of age, inclusive
- •AIS A classification of traumatic spinal cord injury with a neurological level within C5-T1 inclusive
- •Recent injury
- •Non-penetrating SCI
排除标准
- •Terminally ill subjects not likely to be able to participate in follow-up
- •Incomplete spinal cord injury (AIS B, C, D, and E injuries)
- •No identifiable intra-spinal cavity following myelotomy/irrigation in the contused spinal cord in which a Scaffold can be placed
- •Spinal cord injury associated with significant traumatic brain injury or coma that
- •Radiographic or visual evidence of parenchymal dissociation or anatomic transection as determined by the Investigator where the contusion completely bridges a full cross-section of the spinal cord
- •Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds
研究组 & 干预措施
Neuro-Spinal Scaffold
Experimental
干预措施: Neuro-Spinal Scaffold (Device)
结局指标
主要结局
Incidence of all Adverse Device Effects of any kind/seriousness.
时间窗: 6 Months
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
撤回
不适用
Cervical Spinal Cord Stimulation in Cerebral VasospasmCerebral VasospasmNCT02426827Mayo Clinic
Unknown
4 期
Spinal Cord Stimulation (SCS) in Refractory AnginaAngina PectorisNCT00121654Catholic University of the Sacred Heart60
进行中（未招募）
不适用
Brain Controlled Spinal Cord Stimulation In Participants With Spinal Cord Injury For Lower Limb RehabilitationSpinal Cord InjuriesParaplegiaNCT06243952Ecole Polytechnique Fédérale de Lausanne3
已完成
不适用
Safety and Efficacy Vagal Nerve Stimulation in Patients With Rheumatoid ArthritisRheumatoid ArthritisNCT01552941SetPoint Medical Corporation18
已完成
1 期
Minocycline and Perfusion Pressure Augmentation in Acute Spinal Cord InjurySpinal Cord InjuriesNCT00559494University of Calgary52