NCT02440776Unknown不适用
Pathway CH S&E Registry: Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache - ATI Neurostimulation System is Branded Internationally as Pulsante™ Microstimulator System
Autonomic Technologies, Inc.9 个研究点 分布在 5 个国家目标入组 30 人开始时间: 2015年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 9
- 主要终点
- Characterization of all device/procedure related Adverse Events
研究概览
简要总结
Monitor the safety and performance of the Pulsante Microstimulator System.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient meets CE marked labeling for cluster headache.
- •Patient has the ability to read, comprehend and reliably record information as required by the Protocol.
- •Patient is able to provide written informed consent prior to participation in the study.
排除标准
- •Patient has other significant pain problem that might confound the study assessments in the opinion of the Investigator.
结局指标
主要结局
Characterization of all device/procedure related Adverse Events
时间窗: Through five years post implant
Outcome will be assessed at Implant, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post implant.
次要结局
- Acute response to therapy(Through five years post implant)
研究者
研究点 (9)
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