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

Not Applicable

Completed

• Conditions: Breast Hypoplasia
• Interventions: Device: EVERA-RAPHA with 100mmHG; Device: EVERA-RAPHA with 60mmHG

• Registration Number: NCT04185961
• Lead Sponsor: Seoul National University Hospital

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

Study Timeline

• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-01
• Study First Posted: 2019-12-04
• Study Start: 2020-01-06
• Primary Completion: 2020-03-30
• Study Completion: 2020-04-06
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVERA-RAPHA with 100mmHG	EVERA-RAPHA with 100mmHG	EVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks
EVERA-RAPHA with 60mmHG	EVERA-RAPHA with 60mmHG	EVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks

Primary Outcome Measures

Name	Time	Method
change in the breast volume between before and after 4 weeks in test group 1 and test group 2 respectively.	Baseline and after 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
difference the mean breast circumference 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
change in the breast circumference between before and after 4 weeks in test group 1 and test group 2 respectively.	Baseline and after 4 weeks	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.
difference the mean breast volume between test group 1 and test group 2	Baseline and after 4 weeks	difference the mean breast volume between test group 1 and test group 2

Trial Locations

Locations (1)

Seoul National Univ. Bundang Hospital; 🇰🇷 Seongnam-si, Bundang,Gyeonggi-do, Korea, Republic of