NCT01711710进行中（未招募）不适用
Clinical Trial to Evaluate the Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) in Women Aged 22 and Over With Breast Reconstruction or Augmentation Mammoplasty.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 103
- 试验地点
- 4
- 主要终点
- a rate of rupture of 1%
研究概览
简要总结
The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or augmentation
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Over 22 years of age
- •Subjects who want breast augmentation reconstruction following breast cancer, congenital or accidental unbalanced breast size
- •Negative pregnancy test in fertile women
- •Subjects who voluntarily decided the participation of the study and signed the informed consent
- •Subjects who can understand and comply with the instructions and participate during the entire period of the trial
排除标准
- •previous breast reconstruction or augmentation history
- •self -immune disease
- •uncontrolled active infectious disease
- •unable to insert beast implant due to radiotherapy
- •Patients who have recurrent breast cancer or do not treat effectively their cancer
- •Abnormal blood test or ECG result for general anesthesia
- •Patients who cannot MRI scan due to having Metallic substance in the body or Claustrophobia
- •Aesthetic addiction, drug abuse, alcohol abuse
- •Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator
结局指标
主要结局
a rate of rupture of 1%
时间窗: 2 years
All the subjects have been monitored for 2 years and will be checked MRI to define rupture at 6month, 1 year and 2year after the breast implant.
a rate of capsular contracture of 5%
时间窗: 2 years
The Baker classification that divided into 4 stages will be used as a reference to evaluate the capsular contracture. Only stage 3 and 4 will be confirmed as capsular contracture.
次要结局
- a rate of connective tissue disease(2 years)
- Change in life satisfaction(2 years)
- Changes in bust girth and actual measured bra-cup size(2 years)
研究者
研究点 (4)
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