DRKS00013526招募中未知
Evaluation of suitable criteria for the therapy of uterine fibroids by MR-guided high-intensity focused ultrasound (MR-HIFU) - HIFU-Myom
Klinikum der Universität München, Campus Großhadern0 个研究点目标入组 75 人开始时间: 2018年5月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- Female
入选标准
- •1. Age of at least 18 years.
- •2. Current creatinine
- •3. Indication for local ablative therapy by means of HIFU
- •4. Accessibility of the fibroid / fibroids with HIFU
- •5. Funaki Type I-II
- •6. Signed declaration of consent with compliance incl. Follow-up treatment with compliance including follow-up treatment
- •7. Size of fibroid <12 cm
- •8. Exclusion of a leiomyosarcoma
- •9. Signed declaration of consent
排除标准
- •1. Taking Ulipristalacetat (Esmya) over the past 6 months
- •2. General MRI contraindications (pacemakers, metal parts)
- •3. contrast agent allergy
- •4. Significantly reduced general condition
- •5. Massive obesity (BMI> 40)
- •6. Patients with mental / psychiatric disorders
- •7. pregnancy
- •8. intrauterine Device
- •9. Funaki Type III-IV
- •10. Pedunculated serous fibroid
- •11. Detection of a Leiomyosarcoma
研究者
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