NCT01609400已完成不适用
An Extension of CTN 31GB0607 to Evaluate Long Term Safety of NASHA Treatment in the Breast
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
- 11
- 主要终点
- Evaluate if study product has been completely degraded in the breast 6 years post treatment in study 31GB0607, using MRI
研究概览
简要总结
The study evaluates degradation of NASHA in breast 4 and 6 years post treatment, long term safety and evaluation if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast. An independent evaluation of the aesthetic changes is also performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •subject treated with NASHA-gel in the breasts in study 31GB0607
- •signed informed consent
排除标准
- •no exclusion criteria in this study
结局指标
主要结局
Evaluate if study product has been completely degraded in the breast 6 years post treatment in study 31GB0607, using MRI
时间窗: 6 years
Evaluate if study product has been completely degraded in the breast 4 years post treatment in study 31GB0607, using MRI
时间窗: 4 years
次要结局
- Evaluate long term safety of study product in breast enhancement using adverse events reporting, breast examination, ultrasound and mammography.(6 years)
- Evaluate if a satisfactory breast cancer screening can be performed in subjects treated with NASHA-gel in breast(s)(6 years)
- Perform an independent evaluation of aesthetic changes in the treated breasts taking into consideration the aging of the subject, using pre- and post-treatment photos(6 years)
研究者
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