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Completed

NCT Number: NCT04185961

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

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

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Key information

Conditions

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National Univ. Bundang Hospital

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

About this study

  • Subjects who voluntarily signed a consent form and met all inclusion / exclusion criteria should enroll in this study.
  • Subjects enrolled in the study will be randomized and assigned to either Group1 or Group2 in a 1: 1 ratio.
  • Apply EVERA RAPHA for 4 weeks
  • Measure breast circumference and breast volume at Baseline and 4weeks later 4. Visit after 4 weeks to evaluate safety and effectiveness

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

EVERA-RAPHA with 60mmHG

Device

Apply EVERA-RAPHA with 60mmHG for 4weeks

EVERA-RAPHA with 100mmHG

Device

Apply EVERA-RAPHA with 100mmHG for 4weeks

Primary outcomes

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

    Time frame: 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 outcomes

  1. change in the breast circumference between before and after 4 weeks in test group 1 and test group 2 respectively.

    Time frame: 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.

  2. difference the mean breast volume between test group 1 and test group 2

    Time frame: Baseline and after 4 weeks

    difference the mean breast volume between test group 1 and test group 2

  3. difference the mean breast circumference between test group 1 and test group 2

    Time frame: Baseline and after 4 weeks

    difference the mean breast circumference between test group 1 and test group

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2019
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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