NCT03328260已完成不适用
Prospective, Muti-institute, Single Arm, Confirmative Trial Evaluating Efficacy and Safety of High Intensity Focused Ultrasound Device (RODIN) in Women With Symptomatic Uterine Leiomyoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Non perfused volume
研究概览
简要总结
Aim to evaluate the efficacy of safety of newly developed, high intensity focused ultrasound device in women with symptomatic uterine leiomyoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal (FSH < 40 IU/L)
- •Symptomatic uterine fibroids
- •Willing to contracept during study period
排除标准
- •Pregnant or willing to be pregnant in future
- •Cancer in female reproductive organ is suspected or diagnosed
- •Inflammation in female reproductive organ
- •Poorly controlled systemic disease
- •Hematocrit < 25%
- •Glomerular filtration rate(GFR) <= 30ml/min
- •Cannot tolerate contrast-enhanced MR or Contrast-enhanced ultrasound(CEUS)
- •Cannot lie down
- •Previous treatment for leiomyoma, any of ① myolysis, ② myomectomy within 1 year, ③ hormonal therapy longer than 7 days within 4 weeks
- •Cannot count the number or measure volume of leiomyoma using MRI
- •Leiomyomas are inadequate (location, volume, number) for intervention
- •Diameter of leiomyoma is over 5 cm
- •Leiomyoma is not enhanced
- •Lactating women
- •Cannot communicate properly
- •Participating or have participated in other trials within 30 days
研究组 & 干预措施
Treatment
Experimental
干预措施: HIFU (Device)
结局指标
主要结局
Non perfused volume
时间窗: treatment day
Non perfused volume in myoma immediately after ablation
次要结局
未报告次要终点
研究者
研究点 (1)
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