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Efficacy and Safety Study of EVERA to Augment Small Breast

Primary Purpose

Atrophy of Breast

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EVERA
ESTES
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophy of Breast focused on measuring small breast, augmentation, breast volume, External Soft Tissue Expansion System(ESTES)

Eligibility Criteria

24 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National Univ. Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EVERA

ESTES

Arm Description

EVERA- korean ESTES system, apply for 12 weeks

ESTES apply for 12 weeks

Outcomes

Primary Outcome Measures

The change in breast volume of the test group and control group

Secondary Outcome Measures

Changes in satisfaction level on their breast

Full Information

First Posted
December 6, 2013
Last Updated
March 4, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02009137
Brief Title
Efficacy and Safety Study of EVERA to Augment Small Breast
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy of Breast
Keywords
small breast, augmentation, breast volume, External Soft Tissue Expansion System(ESTES)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVERA
Arm Type
Experimental
Arm Description
EVERA- korean ESTES system, apply for 12 weeks
Arm Title
ESTES
Arm Type
Active Comparator
Arm Description
ESTES apply for 12 weeks
Intervention Type
Device
Intervention Name(s)
EVERA
Intervention Description
EVERA apply for 12 weeks
Intervention Type
Device
Intervention Name(s)
ESTES
Intervention Description
ESTES apply for 12 weeks
Primary Outcome Measure Information:
Title
The change in breast volume of the test group and control group
Time Frame
Baseline and 12weeks and 16weeks
Secondary Outcome Measure Information:
Title
Changes in satisfaction level on their breast
Time Frame
Baseline and 12weeks and 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chanyeong - Heo, Ph.D
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National Univ. Bundang Hospital
City
Seongnam-si
State/Province
Gumi-dong, Bundang-gu/Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Efficacy and Safety Study of EVERA to Augment Small Breast

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