Pilot Study to Determine the Optimal Negative Pressure for Non-invasive Breast Augmentation in Women

Study Overview
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Brief Summary
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Aim is to investigate optimum pressure and evaluate safety and effectiveness of EVERA-RAPHA for breast augmentation

Detailed Description
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Subjects who voluntarily signed a consent form and met all inclusion / exclusion criteria should enroll in this study. Subjects enrolled in the study will be randomized and assigned to either Group1 or Group2 in a 1: 1 ratio. 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

Official Title
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A Double-blind Pilot Study to Determine the Optimal Negative Pressure of EVERA-RAPHA for Non-invasive Breast Augmentation in Women

Conditions
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Breast Hypoplasia

Intervention / Treatment
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* Device: EVERA-RAPHA with 60mmHG
* Device: EVERA-RAPHA with 100mmHG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVERA-RAPHA with 60mmHG<br>EVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks | Device: EVERA-RAPHA with 60mmHG<br>* Apply EVERA-RAPHA with 60mmHG for 4weeks<br>|
| Experimental: EVERA-RAPHA with 100mmHG<br>EVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks | Device: EVERA-RAPHA with 100mmHG<br>* Apply EVERA-RAPHA with 100mmHG for 4weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |