Clinical trial NCT04185961: Pilot Study to Determine the Optimal Negative Pressure for Non-invasive Breast Augmentation in Women
Official title: A Double-blind Pilot Study to Determine the Optimal Negative Pressure of EVERA-RAPHA for Non-invasive Breast Augmentation in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Hypoplasia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 16
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief summary: Aim is to investigate optimum pressure and evaluate safety and effectiveness of EVERA-RAPHA for breast augmentation

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. A woman over the age of twenty
2. A woman who wants both breast enlargement
3. A person whose difference between chest circumference and lower chest circumference is less than 10 cm.
4. Subject who sign the consent form of the study and agree to participate in the clinical trial
5. Subject who are willing and able to comply with study protocol

Exclusion Criteria:

1. A woman who has a history of great weight-change
2. A case that Breast cancer or mammary tumour found in basic physical examinations
3. A woman with symptoms or history that suggest she has a fibroblastoma, breast pain, periodic congestion, etc.
4. A woman with severe trauma around the breast.
5. A woman with a scar or skin lesion around the breast.
6. A woman with more than breast ptosis of Grade 3 (the nipple is less than 1-3 cm below the breast)
7. A woman with a history of chronic dermatitis, chronic pressure urticaria, contact dermatitis, etc.
8. A woman who disagrees with contraception
9. A woman who has previously undergone a breast reconstruction or breast augmentation
10. A woman with an uncontrolled active infectious disease

Primary outcomes:
measure: change in the breast volume between before and after 4 weeks in test group 1 and test group 2 respectively.
timeFrame: Baseline and after 4 weeks
Secondary outcomes:
measure: change in the breast circumference between before and after 4 weeks in test group 1 and test group 2 respectively.
timeFrame: Baseline and after 4 weeks
measure: difference the mean breast volume between test group 1 and test group 2
timeFrame: Baseline and after 4 weeks
measure: difference the mean breast circumference between test group 1 and test group 2
timeFrame: Baseline and after 4 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Bundang,Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chan Yeong Heo, Doctor
role: PRINCIPAL_INVESTIGATOR
References: