NCT01616511已完成不适用
Long-Term Follow-Up for the Pathway CH-1 Trial: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache
Autonomic Technologies, Inc.3 个研究点 分布在 3 个国家目标入组 33 人开始时间: 2012年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for the stimulation of the SPG in CH Subjects.
研究概览
简要总结
The objective of the study is to demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for stimulation of the sphenopalatine ganglion (SPG) in cluster headache subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 has been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial.
- •Subject has completed the Pathway CH-1 Open Label Final office visit and remains implanted with an ATI Neurostimulator.
- •Subject has the ability to read, comprehend and to reliably record information as required by the Protocol.
- •Subject is able to provide written informed consent prior to participation in the study.
排除标准
- •Subject has or requires a pacemaker/defibrillator or other implantable device having a sense amplifier that is programmed 'On.'
- •Subject is not suitable for the study for any reason in the judgment of the Investigator.
结局指标
主要结局
Demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for the stimulation of the SPG in CH Subjects.
时间窗: Long-Term
次要结局
未报告次要终点
研究者
研究点 (3)
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