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

Breast Hypoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04185961
• Other study ID #: GNSD_EVRP_2019
• Status: Completed
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: April 6, 2020

Study information

• Verified date: May 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 6, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Hypoplasia

Intervention

Device:
• EVERA-RAPHA with 60mmHG
Apply EVERA-RAPHA with 60mmHG for 4weeks
• EVERA-RAPHA with 100mmHG
Apply EVERA-RAPHA with 100mmHG for 4weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Bundang Hospital	Seongnam-si	Bundang,Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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