NCT01223963已完成不适用
A Multi-center Retrospective Chart Review of Medical Records on the Use of Macrolane Volume Restoration Factor for Breast Enhancement
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This is a retrospective, multicenter chart review of medical records on the use of Macrolane for female breast enhancement.
The primary objective is to evaluate the safety profile of Macrolane Volume Restoration Factor 20 and Macrolane Volume Restoration Factor 30 when used for female breast enhancement in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females treated with Macrolane Volume Restoration Factor 20 and/or Volume Restoration Factor 30 for breast enhancement.
- •Signed Informed Consent
排除标准
- •Subjects that have actively asked not to be contacted by the clinic
- •Subjects that have participated or participates in clinical studies with Macrolane for breast enhancement
结局指标
主要结局
Number of Adverse Events
时间窗: 01may2008 - 31dec2009
Number of Adverse events reported during the study period
次要结局
未报告次要终点
研究者
研究点 (2)
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