NCT06751264进行中(未招募)不适用
Evaluation of the Efficacy and Safety of Microwave Ablation of Uterine Adenomyosis Under Improved Ultrasound Guidance
Peking University Aerospace Center Hospital1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2025年1月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- The rates of endometrial injury
研究概览
简要总结
This study aims to compare the safety and efficacy of segmental power adjustment combined with uterine cavity hydro-isolation in microwave ablation of adenomyosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •UFs or AM diagnosed by pathology and ultrasound;
- •Relevant symptoms such asabnormal uterine bleeding, secondary anemia, progressive dysmenorrhea and enlargement of the uterus;
- •Voluntarily undergo MWA;
- •a confirmed available safe transabdominal puncture path;
排除标准
- •Pregnancy or malignancy;
- •Severe and uncorrectable coagulation disorders;
- •Severe cardiac, liver, and renal dysfunction;
- •Anesthesia allergy.
研究组 & 干预措施
Peritoneal water isolation
Experimental
Peritoneal water isolation
干预措施: Peritoneal water isolation (Procedure)
Peritoneal combined with intrauterine water isolation
Experimental
Peritoneal combined with intrauterine water isolation
干预措施: Peritoneal combined with intrauterine water isolation (Procedure)
结局指标
主要结局
The rates of endometrial injury
时间窗: From enrollment to the end of treatment at 3 months
Observe the differences in the rates of endometrial injury between two groups
次要结局
- The reduction rate of adenomyosis volume(From enrollment to the end of treatment at 1 year)
- complication(From enrollment to the end of treatment at 1 year)
研究者
Liang Lei
Peking University Aerospace Centre Hospital
Peking University Aerospace Center Hospital
研究点 (1)
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