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

NCT04185961 | Completed

• 1 other identifier: GNSD_EVRP_2019
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Hypoplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

  Baseline and after 4 weeks

Study Arms (2)

EVERA-RAPHA with 60mmHG

EXPERIMENTAL

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

Device: EVERA-RAPHA with 60mmHG

EVERA-RAPHA with 100mmHG

EXPERIMENTAL

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

Device: EVERA-RAPHA with 100mmHG

Interventions

EVERA-RAPHA with 60mmHG DEVICE

Apply EVERA-RAPHA with 60mmHG for 4weeks

EVERA-RAPHA with 60mmHG

EVERA-RAPHA with 100mmHG DEVICE

Apply EVERA-RAPHA with 100mmHG for 4weeks

EVERA-RAPHA with 100mmHG

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A woman over the age of twenty
• A woman who wants both breast enlargement
• A person whose difference between chest circumference and lower chest circumference is less than 10 cm.
• Subject who sign the consent form of the study and agree to participate in the clinical trial
• Subject who are willing and able to comply with study protocol

You may not qualify if:

• A woman who has a history of great weight-change
• A case that Breast cancer or mammary tumour found in basic physical examinations
• A woman with symptoms or history that suggest she has a fibroblastoma, breast pain, periodic congestion, etc.
• A woman with severe trauma around the breast.
• A woman with a scar or skin lesion around the breast.
• A woman with more than breast ptosis of Grade 3 (the nipple is less than 1-3 cm below the breast)
• A woman with a history of chronic dermatitis, chronic pressure urticaria, contact dermatitis, etc.
• A woman who disagrees with contraception
• A woman who has previously undergone a breast reconstruction or breast augmentation
• A woman with an uncontrolled active infectious disease

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National Univ. Bundang Hospital

Seongnam-si, Bundang,Gyeonggi-do, 463-707, South Korea

Location

Study Officials

• Chan Yeong Heo, Doctor

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A Double-blind Pilot Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: EVERA-RAPHA with 60 mmHg: EVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks EVERA-RAPHA with 100 mmHg: EVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 4, 2019
• Study Start: January 6, 2020
• Primary Completion: March 30, 2020
• Study Completion: April 6, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)