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OpenTrials
Completed

NCT Number: NCT02009137

Efficacy and Safety Study of EVERA to Augment Small Breast

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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Key information

Conditions

Atrophy of Breast

Age range

24 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National Univ. Bundang Hospital

Seongnam-si, Gumi-dong, Bundang-gu/Gyeonggi-do, 463-707, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVERA

Device

EVERA apply for 12 weeks

ESTES

Device

ESTES apply for 12 weeks

Primary outcomes

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

    Time frame: Baseline and 12weeks and 16weeks

Secondary outcomes

  1. Changes in satisfaction level on their breast

    Time frame: Baseline and 12weeks and 16 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Randomized-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Breast Augmentation With EVERA(Korean External Soft Tissue Expansion System) as Compared to AESTES (American External Soft Tissue Expansion

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2013
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.