NCT05569200尚未招募不适用
The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluation of tumour response
研究概览
简要总结
Uterine benign tumor including myoma is the most common female benign pelvic tumor. Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) has been considered to be a minimal invasive treatment. The device used in this trial will be Haifu Focused Ultrasound tumor therapeutic System. In this trial, the investigators will observe the possibility of complication and tumor response of treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Benign uterine fibroids.
- •Women over the age of
- •Abdominal circumference <100 cm.
- •The largest fibroids are ≥ 4 cm.
排除标准
- •Pregnant women or those with positive pregnancy test results.
- •Those with other pelvic diseases.
- •Those with immune diseases.
- •There are unsuitable interfaces in the ultrasonic treatment path.
- •Those with tumor calcification.
- •People with severe heart, blood vessel and kidney disease.
- •Those with abnormal coagulation function and low platelets.
- •Type III fibroids according to Funaki classification
结局指标
主要结局
Evaluation of tumour response
时间窗: 3 month after treatment
Evaluation of tumour response according to the modified RECIST criteria by sequencing MR imaging
次要结局
未报告次要终点
研究者
研究点 (1)
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