NCT02139683已完成不适用
High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Theraclion
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in size of fibroadenomata as recorded on ultrasound imaging
研究概览
简要总结
The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..
详细描述
Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years of age
- •Fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on patients <25 and ultrasound plus core-biopsy in patients >25 (Graded B2 or less)
- •Visible on ultrasound (Graded U2/U3)
- •Definitive diagnosis of fibroadenomata confirmed by the Breast multi-disciplinary team meeting (MDT).
排除标准
- •Lesion with atypia or suspicion of phyllodes (Graded B3 or greater)
- •Pregnant or lactating women
- •History of laser or radiation therapy to the targeted breast
研究组 & 干预措施
HIFU treatment
Experimental
HIFU treatment in patient diagnosed with fibroadenoma
干预措施: HIFU treatment (Device)
结局指标
主要结局
Changes in size of fibroadenomata as recorded on ultrasound imaging
时间窗: Month 1, Month 3, Month 12
次要结局
- Patient recorded outcomes measures(Month 1, Month 3, Month 12)
- Adverse Events(Month 1, Month 3, Month 12)
- Mean treatment time(Treatment visit date)
- Cost-effectiveness(12 months)
研究者
研究点 (2)
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