A Double-blind Pilot Study to Determine the Optimal Negative Pressure of EVERA-RAPHA for Non-invasive Breast Augmentation in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- change in the breast volume between before and after 4 weeks in test group 1 and test group 2 respectively.
研究概览
简要总结
Aim is to investigate optimum pressure and evaluate safety and effectiveness of EVERA-RAPHA for breast augmentation
详细描述
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Subjects who voluntarily signed a consent form and met all inclusion / exclusion criteria should enroll in this study.
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Subjects enrolled in the study will be randomized and assigned to either Group1 or Group2 in a 1: 1 ratio.
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Apply EVERA RAPHA for 4 weeks
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Measure breast circumference and breast volume at Baseline and 4weeks later 4. Visit after 4 weeks to evaluate safety and effectiveness
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
- Double (Participant, Outcomes Assessor)
盲法说明
A Double-blind Pilot Study
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A woman over the age of twenty
- •A woman who wants both breast enlargement
- •A person whose difference between chest circumference and lower chest circumference is less than 10 cm.
- •Subject who sign the consent form of the study and agree to participate in the clinical trial
- •Subject who are willing and able to comply with study protocol
排除标准
- •A woman who has a history of great weight-change
- •A case that Breast cancer or mammary tumour found in basic physical examinations
- •A woman with symptoms or history that suggest she has a fibroblastoma, breast pain, periodic congestion, etc.
- •A woman with severe trauma around the breast.
- •A woman with a scar or skin lesion around the breast.
- •A woman with more than breast ptosis of Grade 3 (the nipple is less than 1-3 cm below the breast)
- •A woman with a history of chronic dermatitis, chronic pressure urticaria, contact dermatitis, etc.
- •A woman who disagrees with contraception
- •A woman who has previously undergone a breast reconstruction or breast augmentation
- •A woman with an uncontrolled active infectious disease
研究组 & 干预措施
EVERA-RAPHA with 60mmHG
EVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks
干预措施: EVERA-RAPHA with 60mmHG (Device)
EVERA-RAPHA with 100mmHG
EVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks
干预措施: EVERA-RAPHA with 100mmHG (Device)
结局指标
主要结局
change in the breast volume between before and after 4 weeks in test group 1 and test group 2 respectively.
时间窗: Baseline and after 4 weeks
change in the breast volume between before and after 4 weeks of wearing the medical device in test group 1 and test group 2 respectively.
次要结局
- difference the mean breast circumference between test group 1 and test group 2(Baseline and after 4 weeks)
- change in the breast circumference between before and after 4 weeks in test group 1 and test group 2 respectively.(Baseline and after 4 weeks)
- difference the mean breast volume between test group 1 and test group 2(Baseline and after 4 weeks)