Prospective Observational Study of Microwave Ablation of Uterine Fibroids (MyoMwa)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Symptom severity of uterine fibroids and quality of life
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 or symptomatic uterine fibroids. We will include 100 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
- 18 Years 至 56 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •symptomatic fibroids
- •premenopausal status
- •acceptable risks for general anestesia or sedation
- •willing to undergo mwa treatment and participate in the study
排除标准
- •postmenopausal status
- •bleeding disorder with increased risk of bleeding
研究组 & 干预措施
patients with symptomatic uterine fibroids
Patients with symptomatic uterine fibroids, who will undergo microwave ablation of fibroids as a clinical treatment are recruited in this study.
干预措施: microwave ablation (Procedure)
结局指标
主要结局
Symptom severity of uterine fibroids and quality of life
时间窗: 12 months
Score of validated form Uterine Fibroid symptom - Quality of life questinnaire. minimum 0, maximum 100 where higher scores indicate higher symptom severity
suitability of mwa for general fibroid population
时间窗: 12 months
objective and subjective outcome of mwa in different fibroid types, sizes and locations
次要结局
未报告次要终点
研究者
Kirsi Joronen
Principal Investigator
Turku University Hospital