NL-OMON43988已完成不适用
Targeted vessel ablation of type 3 uterine fibroids with magnetic resonance guided high intensity focused ultrasound - HIFU-TVA of type 3 fibroids
niversitair Medisch Centrum Utrecht0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Women, aged at least 18 years;
- •- Able to give informed consent;
- •- A type 3 uterine fibroid;
- •- Sufficient physical condition to undergo deep sedation;
- •- Waist circumference that allows positioning on the HIFU table top inside the MR bore.
排除标准
- •- Contra-indication for MRI scanning according to the hospital guidelines;
- •- Contra-indication to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast agent, and renal failure (GFR < 30 mL/min/1.73 m2);
- •- Surgical clips or considerable scar tissue in the HIFU beam path;
- •- A total of more than ten fibroids;
- •- Post- or peri-menopausal status;
- •- Fibroid size >10 cm in diameter;
- •- Patient has an active pelvic infection;
- •- Patient has an undiagnosed pelvic mass outside the uterus;
- •- Patient who is not able to tolerate the required stationary prone position during treatment.
研究者
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