NCT04571307Unknown不适用
Pilot Study on the Feasibility of Cryotherapy as an Alternative Treatment for Phyllodes Tumors/Breast Fibroepithelial Lesions (FELs) Needing Surgery
KK Women's and Children's Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- breast cosmetic outcome
研究概览
简要总结
To determine the feasibility of cryotherapy for B3 fibroepithelial lesions
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •lesion seen on ultrasound
- •core biopsy revealed FEL of B3
- •lesion </+3.5cm
- •keen for cryotherapy instead of surgery
- •has other breast lesions for followup
排除标准
- •cancer patients
- •patients with bleeding diathesis
- •lesions causing visible breast deformity
结局指标
主要结局
breast cosmetic outcome
时间窗: at 1 year post procedure
patient self assessment of excellent (1), good (2), fair (3) poor (4). score of 1-4,1 being the best score
recurrence of the lesion
时间窗: 2 years from procedure
assessed on ultrasound
pain score
时间窗: at 2 weeks post procedure
using pain score scale of 0-10, a higher score indicates a worse outcome
次要结局
未报告次要终点
研究者
研究点 (1)
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