NCT00910312已完成不适用
Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 5
- 主要终点
- engulfment of the tumor by the ice-ball as seen under ultrasound imaging
研究概览
简要总结
The purpose of this study is to determine whether the Ice-Sense, a novel cryotherapy system (a system that freezes tissues), is safe and effective in the treatment of benign breast tumors such as fibroadenoma.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient is above 18 years old.
- •Patient has breast fibroadenoma, proven by biopsy (Core Biopsy).
- •Patient's fibroadenoma can be visualized with ultrasound.
- •Patient's fibroadenoma size is between 0.5cm and 3cm at its largest dimension.
- •Patient is able to visit the clinic as needed during the 12-month follow-up period following the cryoablation procedure.
- •The patient has been informed of the study and agrees to its provisions, and has signed an IRB/EC approved written informed consent, including data privacy authorization.
排除标准
- •Patients with history of breast cancer.
- •Women with known pregnancy.
- •Patients with superficial fibroadenoma very close to the skin.
- •Patient has undergone major surgery within the previous 12 weeks.
- •Patients with any terminal illness, or with a life expectancy <2 year.
- •Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS.
- •Patient participating in other trials using drugs or devices.
结局指标
主要结局
engulfment of the tumor by the ice-ball as seen under ultrasound imaging
时间窗: during the procedure
次要结局
- any device related adverse events or complications that may occur(one year)
研究者
研究点 (5)
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