Efficacy and Safety Study of EVERA to Augment Small Breast

March 4, 2015 updated by: Chan-Yeong Heo, Seoul National University Hospital

A Randomized-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Breast Augmentation With EVERA(Korean External Soft Tissue Expansion System) as Compared to AESTES (American External Soft Tissue Expansion

Expected Total Number of Subjects

  • Level of significance, alfa 0.05
  • Power 0.80
  • Mean difference between two treatments is assumed 35
  • Standard Deviation is assumed 35.
  • Follow-up loss is assumed 20%
  • N=34(each group:17)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design

  • single center, randomized, unblind clinical study Medical device
  • Investigational Medical Device: EVERA
  • Comparator: ESTES Process
  • For eligible subjects, investigator apply Standard Deviation or Comparator on the breast
  • The Investigational Medical Device is determined by randomization.
  • Subjects will be applied for 12 weeks.
  • Subjects will receive Patient Compliance Diary
  • Subjects will visit the hospital to measure breast volume with VIVID 9i every 2 weeks for 16weeks

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female aged between 24 and 40
  • BMI of over 20
  • Subjects who want to augment breasts
  • Subjects who understand the study contents and signed the informed consent
  • Subjects who can follow study procedure

Exclusion Criteria:

  • Pregnant or Lactating subjects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EVERA
EVERA- korean ESTES system, apply for 12 weeks
Device: EVERA
EVERA apply for 12 weeks
ACTIVE_COMPARATOR: ESTES
ESTES apply for 12 weeks
Device: ESTES
ESTES apply for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in breast volume of the test group and control group
Time Frame: Baseline and 12weeks and 16weeks
Baseline and 12weeks and 16weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in satisfaction level on their breast
Time Frame: Baseline and 12weeks and 16 weeks
Baseline and 12weeks and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

December 6, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E1307-210-002
  • 06-2013-175-GNSD (OTHER_GRANT: GNSD Co.,Ltd)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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