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临床试验/NCT02914704
NCT02914704招募中不适用

Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU)

Turku University Hospital2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年1月最近更新:
适应症
干预措施

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

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

Experimental

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

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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