Efficacy and Safety Study of EVERA to Augment Small Breast

Not Applicable

Completed

• Conditions: Atrophy of Breast
• Interventions: Device: EVERA; Device: ESTES

• Registration Number: NCT02009137
• Lead Sponsor: Seoul National University Hospital

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

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

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Exclusion Criteria

• Pregnant or Lactating subjects

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVERA	EVERA	EVERA- korean ESTES system, apply for 12 weeks
ESTES	ESTES	ESTES apply for 12 weeks

Primary Outcome Measures

Name	Time	Method
The change in breast volume of the test group and control group	Baseline and 12weeks and 16weeks

Secondary Outcome Measures

Name	Time	Method
Changes in satisfaction level on their breast	Baseline and 12weeks and 16 weeks

Trial Locations

Locations (1)

Seoul National Univ. Bundang Hospital; 🇰🇷 Seongnam-si, Gumi-dong, Bundang-gu/Gyeonggi-do, Korea, Republic of