NCT02009137已完成不适用
A Randomized-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Breast Augmentation With EVERA(Korean External Soft Tissue Expansion System) as Compared to AESTES (American External Soft Tissue Expansion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- The change in breast volume of the test group and control group
研究概览
简要总结
Expected Total Number of Subjects
- Level of significance, alfa 0.05
- Power 0.80
- Mean difference between two treatments is assumed 35
- Standard Deviation is assumed 35.
- Follow-up loss is assumed 20%
- N=34(each group:17)
详细描述
Study design
- single center, randomized, unblind clinical study Medical device
- Investigational Medical Device: EVERA
- Comparator: ESTES Process
- For eligible subjects, investigator apply Standard Deviation or Comparator on the breast
- The Investigational Medical Device is determined by randomization.
- Subjects will be applied for 12 weeks.
- Subjects will receive Patient Compliance Diary
- Subjects will visit the hospital to measure breast volume with VIVID 9i every 2 weeks for 16weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female aged between 24 and 40
- •BMI of over 20
- •Subjects who want to augment breasts
- •Subjects who understand the study contents and signed the informed consent
- •Subjects who can follow study procedure
排除标准
- •Pregnant or Lactating subjects
结局指标
主要结局
The change in breast volume of the test group and control group
时间窗: Baseline and 12weeks and 16weeks
次要结局
- Changes in satisfaction level on their breast(Baseline and 12weeks and 16 weeks)
研究者
Chan-Yeong Heo
Assistant Professor
Seoul National University Hospital
研究点 (2)
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