NCT03535610已完成不适用
Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.
Scitech Produtos Medicos Ltda2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年8月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Uterine Volume Reduction
研究概览
简要总结
To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients from 18 to 50 years old;
- •symptomatic uterine intramural leiomyomas or multiple symptomatic leiomyomas in the presence of intramural;
- •patient agrees with study procedures;
- •patient signs the informed consent form.
排除标准
- •asymptomatic women;
- •isolated adenomyosis, pediculated subserous myoma, submucous leiomyoma (50% of uterine cavity diameter), intraligamentous leiomyoma;
- •leiomyoma diameter higher than 10 cm;
- •leiomyoma above the umbilical scar;
- •endometrial neoplasia or hyperplasia or presence of any malignancy
- •pregnant or breast feeding women;
- •active vasculitis;
- •pelvic irradiation history;
- •uncontrolled coagulopathies;
- •renal insufficiency;
- •contrast allergy;
- •concomitant use of GnRH analogues.
结局指标
主要结局
Uterine Volume Reduction
时间窗: 6 months
Uterine Volume Reduction measured by MRI
Fibroid Reduction
时间窗: 6 months
Fibroid Reduction measured by MRI
次要结局
- Ovarian Function(6 months)
- Quality of Life Improvement(6 months)
研究者
研究点 (2)
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