Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- InSightec
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
The goal of this Registry Study is to capture clinical pregnancy outcomes and fibroid treatment background data for any subject post-Exablate treatment for their symptomatic fibroids.
详细描述
This is an observational study only for all consented subjects who undergo an Exablate treatment. The Exablate procedure is a commercial treatment. The objective of this registry is to collect data about the effect of Exablate treatment on potential pregnancy occurrences in this population for two years post-treatment for purposes of labeling updates and overall safety data collection.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Eligibility is as per the symptomatic fibroids device indication. - All registry-consented patients following the treatment of their fibroid(s) with the Exablate system.
排除标准
- 未提供
结局指标
主要结局
Occurrence of adverse events
时间窗: Through study completion, an average of 2 years.
All adverse events and/or serious adverse events will be documented and reported according to protocol.
次要结局
未报告次要终点