NCT00821275Unknown2 期
Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma
Sun Yat-sen University4 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2008年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 900
- 试验地点
- 4
- 主要终点
- quality of life
研究概览
简要总结
The efficacy and safety of uterine artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief, complication, fertility, ovarian function and quality of life with uterine artery embolization for uterine fibroids comparing with standard surgical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of symptomatic uterine leiomyoma
排除标准
- •pregnancy
- •iodine agent allergy
- •patient refuse to take part in this trial
- •tumour size is less than 3cm or beyond 10cm
- •with endometriosis
- •with malignant diseases
- •with abnormal coagulation function which can't restore
- •with acute inflammatory diseases or acute episode of chronic inflammatory diseases
- •with severe heart, lung, liver and kidney, et al. organ diseases.
结局指标
主要结局
quality of life
时间窗: 1,3,5,10 year.
pregnant
时间窗: 3 years
次要结局
- tumor recurrence(1,3,5,10 years)
- complications(3,6,12,24 months)
- ovarian functions(3,6,12 months, 2,3,5 and 10 years)
- symptom relief(3,6,12,24 months)
- tumour volume(3,6,12 18 24 months and 3,5,10 years)
研究者
研究点 (4)
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