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

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

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

Study Overview

• Status: Completed
• Conditions: Breast Hypoplasia
• Intervention / Treatment: Device: EVERA-RAPHA with 60mmHG; Device: EVERA-RAPHA with 100mmHG

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang,Gyeonggi-do
    • Seongnam-si, Bundang,Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National Univ. Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EVERA-RAPHA with 60mmHG; EVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks	Device: EVERA-RAPHA with 60mmHG; Apply EVERA-RAPHA with 60mmHG for 4weeks
EXPERIMENTAL: EVERA-RAPHA with 100mmHG; EVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks	Device: EVERA-RAPHA with 100mmHG; Apply EVERA-RAPHA with 100mmHG for 4weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Chan Yeong Heo, Doctor, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2020
• Primary Completion (ACTUAL): March 30, 2020
• Study Completion (ACTUAL): April 6, 2020

Study Registration Dates

• First Submitted: December 1, 2019
• First Submitted That Met QC Criteria: December 1, 2019
• First Posted (ACTUAL): December 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: GNSD_EVRP_2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No