Global Registry: ExAblate 4000 Transcranial MR Guided Focused Ultrasound (TcMRgFUS) of Neurological Disorders:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- InSightec
- 入组人数
- 500
- 试验地点
- 9
- 主要终点
- Clinical Rating Scale for Tremor
研究概览
简要总结
A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum.
详细描述
A global, multi-center, open-label, observational registry to capture safety and effectiveness data related to ExAblate Neuro, an MRI guided focused ultrasound device designed to lesion tissue deep within the brain using sound waves without the need for craniotomy. This registry includes certain regional and country specific approved thalamotomy and pallidotomy procedures using ExAblate Neuro for the treatment of various neurologic disorders such as essential tremor, Parkinson's movement disorders, and neuropathic pain. Treatment targets/indications are country/region dependent based on approved labeling within that region.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets labeling indication for use per information for prescribers
- •Target is accessible by Focused Ultrasound per treatment planning parameters
排除标准
- •Do not agree to participate or who are unlikely to participate over an extended period of time
结局指标
主要结局
Clinical Rating Scale for Tremor
时间窗: 5 year
CRST
次要结局
未报告次要终点