A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- InSightec
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Long-term adverse events.
研究概览
简要总结
The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.
详细描述
This is a post-approval registry which is required by of the approval under PMA P150038/S006 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral thalamotomy in the treatment of medication refractory Tremor Dominant Parkinson's Disease (TDPD). Subjects participating in this registry will have received a unilateral thalamotomy (ventralis medius) prior to enrollment using the commercially available Exablate Neuro for the treatment of Essential tremor and TDPD.
The following assessments will be collected at Baseline,1, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years:
- Adverse Events (AEs) (does not apply to Baseline Visit)
- Medication usage
- Clinical Rating Scale for Tremor (CRST) ON medication
- Unified Parkinson's Disease Rating Scale Part III ON medication
- EQ-5D-5L
- WPAI-GH
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, age 30 years and older
- •Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care.
- •Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits
- •Subject has signed and received a copy of the approved informed consent form
排除标准
- •Subject does not agree to participate or is unlikely to participate for the entirety of the study.
结局指标
主要结局
Long-term adverse events.
时间窗: Five years.
This registry will collect the long-term safety data after performing thalamotomy for TDPD using the Exablate Neuro system.
次要结局
- Tremor/motor intensity and impact on disability(Five years.)