Efficacy and Safety Study of EVERA to Augment Small Breast

N/ACompletedNCT02009137

Seoul National University Hospital34 enrolled

Overview

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 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrophy of Breast

Interventions

EVERADEVICE

EVERA apply for 12 weeks

ESTESDEVICE

ESTES apply for 12 weeks

Eligibility

Sex: FEMALEMin age: 24 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National Univ. Bundang Hospital

Seongnam-si, Gumi-dong, Bundang-gu/Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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

Time frame: Baseline and 12weeks and 16weeks

Secondary Outcomes

Changes in satisfaction level on their breast

Time frame: Baseline and 12weeks and 16 weeks

Data from ClinicalTrials.gov

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