Aim is to investigate optimum pressure and evaluate safety and effectiveness of EVERA-RAPHA for breast augmentation
1. Subjects who voluntarily signed a consent form and met all inclusion / exclusion criteria should enroll in this study. 2. Subjects enrolled in the study will be randomized and assigned to either Group1 or Group2 in a 1: 1 ratio. 3. Apply EVERA RAPHA for 4 weeks 3\. Measure breast circumference and breast volume at Baseline and 4weeks later 4. Visit after 4 weeks to evaluate safety and effectiveness
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
Apply EVERA-RAPHA with 60mmHG for 4weeks
Apply EVERA-RAPHA with 100mmHG for 4weeks
Seoul National Univ. Bundang Hospital
Seongnam-si, Bundang,Gyeonggi-do, South Korea
change in the breast volume between before and after 4 weeks in test group 1 and test group 2 respectively.
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.
Time frame: 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.
change in the breast circumference between before and after 4 weeks of wearing the medical device in test group 1 and test group 2 respectively.
Time frame: Baseline and after 4 weeks
difference the mean breast volume between test group 1 and test group 2
difference the mean breast volume between test group 1 and test group 2
Time frame: Baseline and after 4 weeks
difference the mean breast circumference between test group 1 and test group 2
difference the mean breast circumference between test group 1 and test group
Time frame: Baseline and after 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.