Efficacy and Safety Study of EVERA to Augment Small Breast

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-08-31

Brief Summary

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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)

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Detailed Description

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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

Conditions

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Atrophy of Breast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EVERA

EVERA- korean ESTES system, apply for 12 weeks

Group Type EXPERIMENTAL

EVERA

Intervention Type DEVICE

EVERA apply for 12 weeks

ESTES

ESTES apply for 12 weeks

Group Type ACTIVE_COMPARATOR

ESTES

Intervention Type DEVICE

ESTES apply for 12 weeks

Interventions

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EVERA

EVERA apply for 12 weeks

Intervention Type DEVICE

ESTES

ESTES apply for 12 weeks

Intervention Type DEVICE

Eligibility Criteria

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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