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
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
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
NCT ID
NCT02009137
First Posted
December 6, 2013
Last Updated
March 4, 2015
Sponsor
Seoul National University Hospital
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
Learn more about this trial
Efficacy and Safety Study of EVERA to Augment Small Breast
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