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

Seoul National University

Status: Completed

Conditions: Breast Hypoplasia

Treatments: Device: EVERA-RAPHA with 100mmHG; Device: EVERA-RAPHA with 60mmHG

Study type: Interventional

Funder types: Other

Identifiers

NCT04185961

GNSD_EVRP_2019

Details and patient eligibility

About

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

Full 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

4. Measure breast circumference and breast volume at Baseline and 4weeks later 4. Visit after 4 weeks to evaluate safety and effectiveness

Enrollment: 16 patients

Sex: Female

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

EVERA-RAPHA with 60mmHG

Experimental group

Description:

EVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks

Treatment:

Device: EVERA-RAPHA with 60mmHG

EVERA-RAPHA with 100mmHG

Experimental group

Description:

EVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks

Treatment:

Device: EVERA-RAPHA with 100mmHG