NCT04240262招募中不适用
Prospective Observational Trial of Microwave Ablation for Leiomyoma (MYOMIC2)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Symptom severity of uterine fibroids
研究概览
简要总结
This prospective observational study aims to evaluate the effectiveness and acceptability of percutaneous or vaginal ultrasound guided microwave ablation for the treatment of symptoms related to uterine fibroids. We will include 200 women.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •premenopausal
- •no future child wish
- •acceptable risks for general anestesia or sedation
- •willing to comply with protocol
排除标准
- •current or future child wish
- •bleeding disorder with increased risk of bleeding
结局指标
主要结局
Symptom severity of uterine fibroids
时间窗: 6 months post treatment
Score of validated form Uterine Fibroid symptom- Quality of Life questionnaire. minumum 0, maximum 100 where higher scores indicate higher symptom severity
次要结局
- Quality of Life score(6 months post treatment)
- acceptability(2 hours post treatment and 6 months post treatment (+/- 2 weeks))
- menstrual bleeding(6 months post treatment)
研究者
Helena Kopp Kallner
Senior consultant ob/gyn
Karolinska Institutet
研究点 (1)
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