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Efficacy and Safety Study of EVERA to Augment Small Breast

NCT02009137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2015-03-05

No results posted yet for this study

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)

Conditions

  • Atrophy of Breast

Interventions

DEVICE

EVERA

EVERA apply for 12 weeks

DEVICE

ESTES

ESTES apply for 12 weeks

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Chanyeong - Heo, Ph.D · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-07-31
Completion
2014-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02009137 on ClinicalTrials.gov