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Aim is to investigate optimum pressure and evaluate safety and effectiveness of EVERA-RAPHA for breast augmentation
3. Measure breast circumference and breast volume at Baseline and 4weeks later 4. Visit after 4 weeks to evaluate safety and effectiveness
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVERA-RAPHA with 60mmHG | Experimental | EVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks |
|
| EVERA-RAPHA with 100mmHG | Experimental | EVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVERA-RAPHA with 60mmHG | Device | Apply EVERA-RAPHA with 60mmHG for 4weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and after 4 weeks |
| difference the mean breast volume between test group 1 and test group 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chan Yeong Heo, Doctor | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Univ. Bundang Hospital | Seongnam-si | Bundang,Gyeonggi-do | 463-707 | South Korea |
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EVERA-RAPHA with 60 mmHg: EVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks EVERA-RAPHA with 100 mmHg: EVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks
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A Double-blind Pilot Study
| EVERA-RAPHA with 100mmHG |
| Device |
Apply EVERA-RAPHA with 100mmHG for 4weeks |
|
difference the mean breast volume between test group 1 and test group 2 |
| 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 | Baseline and after 4 weeks |