NCT01050959已完成不适用
Compassionate Use Study of the Bion for Occipital Nerve Stimulation for Treatment of Chronic Headaches
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Provision of one year of clinical and technical support
研究概览
简要总结
The purpose of this compassionate use study is to provide clinical and technical support of the Bion® microstimulator system to the subjects who have decided to keep the system for relief of headache symptoms that have not responded to medical treatment. These study subjects were enrolled and implanted with the Bion® system during a previous clinical investigation of the Bion® for occipital nerve stimulation (ONS) in the United States.
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
- •Subject participated in a prior clinical feasibility study of the Bion for occipital nerve stimulation in the treatment of chronic headaches (IDE G030225) and remained implanted with the Bion system.
- •Subject elects to enroll in this compassionate use study and provides written informed consent.
- •Subject understands the type and duration of clinical, technical or product support provided in the study.
- •Subject is willing to comply with protocol-required activities.
排除标准
- •Subject is currently participating or intends to participate in another investigational drug or device clinical trial for chronic headaches during the study period.
结局指标
主要结局
Provision of one year of clinical and technical support
This is a compassionate use study. There are no primary outcome measures.
次要结局
未报告次要终点
研究者
研究点 (2)
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