Atrophy of Breast
Conditions
Keywords
small breast, augmentation, breast volume, External Soft Tissue Expansion System(ESTES)
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
Interventions
DEVICEEVERA
EVERA apply for 12 weeks
DEVICEESTES
ESTES apply for 12 weeks
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
24 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in breast volume of the test group and control group | Baseline and 12weeks and 16weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in satisfaction level on their breast | Baseline and 12weeks and 16 weeks |
Countries
South Korea
Outcome results
None listed