NCT01874652已完成2 期
Assessment of Safety & Efficacy of Light Weight Breast Implant
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- No reoperation
研究概览
简要总结
The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast Implant (LWBI) in breast augmentation.
详细描述
This is a Single-center. The purpose of the study is to evaluate safety and effectiveness of LWBI in breast augmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Genetic women at ages 18 to 65 seeking breast enlargement
- •Signed informed consent
- •Agreement to complete all required follow up visits
- •A medically acceptable candidate
- •Sufficient breast tissue for proper implant coverage (≥20 mm by pinch test)
排除标准
- •Patients with active infection anywhere in their body
- •Women who are currently pregnant or nursing
- •Insufficient tissue covering in the prospective area of implantation (e.g. after preceding breast reduction), radiation damage or reduced vascularization
- •Abscesses, malignant tumors(cancer or recurrent metastases), advanced fibrocystic diseases
- •Patients with a history of psychiatric treatment
- •Patients that been implanted with any silicone implant (e.g. silicone artificial joints, facial implants)
- •Expected allergies or extraordinary immune response to implants
- •Wound healing impairments or heavy burn scars
- •Existing costal injuries
- •The Patient Participated in an investigational trial within 30 days of enrollment
研究组 & 干预措施
Light Weight Breast Implants
Experimental
Assessment of Safety and Efficacy of Light Weight Breast Implant
干预措施: Light Weight Breast Implants (Device)
结局指标
主要结局
No reoperation
时间窗: during 6 months follow up period
次要结局
- Duration for all adverse events (AEs) on per patient and per implant basis will be recorded and analyzed.(6 month)
研究者
研究点 (1)
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