NCT00774059撤回不适用
Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Result after using the breast lift system,recurrence of ptosis.
研究概览
简要总结
The study is using a new breast lift system to complement a breast-lift operation.
In general there will be recurrence of breast-ptosis after a correcting operation.
With this device we want to minimize this recurrence and provide an "internal bra".
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1.Female subject between 30-50 years of age
- •Subject is referred for mastopexy(breast lifting)due to one of the following reasons:
- •Breast ptosis grade I or II (minimal invasive)
- •Breast ptosis grade I to IV (open procedure)
- •pseudoptosis following breast reduction surgery
- •subject willing to participate as evidenced by signing the written informed consent
- •Minimal invasive: breast cup size <C
排除标准
- •Pregnant or lactating women
- •history of surgical procedures involving the ribs and rib cage
- •Osteoporosis
- •breast implants
- •breast carcinoma
- •auto-immune disease -
结局指标
主要结局
Result after using the breast lift system,recurrence of ptosis.
时间窗: one year
次要结局
- complications(one year)
研究者
研究点 (2)
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