Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score
研究概览
简要总结
MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and effective method in treating uterine fibroids and also adenomyosis. However, systematic studies on the effect of this treatment on factors affecting fertility are still lacking. Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this study is to obtain more information on the systemic response of the body to the HIFU-treatment when treating non-malignant disease as well as to study the effect of MRI-HIFU on factors affecting fertility. Women with symptomatic uterine fibroids or adenomyosis suitable for MRI-HIFU treatment are recruited to this study. The severity of symptoms will be assessed with UFS-QoL and the same questionnaire will also be used in follow-up 3, 6 and 12 months after treatment. Blood, urine and endometrium samples will be collected pre- and postoperatively and during follow-up 3, 6 and 12 months after the treatment. From these samples detailed analysis of the immunological, inflammatory and hormonal response will be performed. As this is the first study in Finland of treating uterine fibroids and adenomyosis using MRI-HIFU, also a report about the efficacy of the MRI-HIFU in treating the uterine disorders will be published, and a key tool in assessing the treatment outcome would be the UFS-QoL questionnaire.
Also new methods for improving patient selection as well as treatment efficacy will be evaluated in this study.
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
- 是
入选标准
- •BMI < 35
- •Premenopausal
- •Uterine size <20 gw
- •Willingness to participate to the research
- •Uterine fibroids with typical symptoms
- •Maximum of 4 treated fibroids
- •Dominant fibroid >2.5cm
- •>50% of the fibroid is treatable
- •Exclusion criteria
- •Unspecified pelvic tumours or ovarian masses, PID
- •Major corrective surgery to uterus (simple myomectomy excluded)
- •Major uterine anomalies
- •Unability to calculate the volume of uterine fibroids
- •Marked uterine calcification
- •Marked scarring of the lower abdomen
- •Suspicion of malignancy
- •Marked general health problem contraindicating MRI
- •Claustrophobia
排除标准
- 未提供
研究组 & 干预措施
Patients treated with MRI-HIFU
干预措施: MRI-HIFU (Device)
结局指标
主要结局
Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score
时间窗: 12 months after treatment
次要结局
未报告次要终点
