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

NCT ID: NCT04185961

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2020-04-06

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

Conditions

Breast Hypoplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EVERA-RAPHA with 60mmHG

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

Group Type: EXPERIMENTAL

EVERA-RAPHA with 60mmHG

Intervention Type: DEVICE

Apply EVERA-RAPHA with 60mmHG for 4weeks

EVERA-RAPHA with 100mmHG

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

Group Type: EXPERIMENTAL

EVERA-RAPHA with 100mmHG

Intervention Type: DEVICE

Apply EVERA-RAPHA with 100mmHG for 4weeks

Interventions

EVERA-RAPHA with 60mmHG

Apply EVERA-RAPHA with 60mmHG for 4weeks

Intervention Type: DEVICE

EVERA-RAPHA with 100mmHG

Apply EVERA-RAPHA with 100mmHG for 4weeks

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chan Yeong Heo, Doctor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National Univ. Bundang Hospital

Seongnam-si, Bundang,Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

GNSD_EVRP_2019

Identifier Type: -

Identifier Source: org_study_id