Efficacy and Safety Study of EVERA to Augment Small Breast

Seoul National University

Status: Completed

Conditions: Atrophy of Breast

Treatments: Device: EVERA; Device: ESTES

Study type: Interventional

Funder types: Other

Identifiers

NCT02009137

E1307-210-002

06-2013-175-GNSD (Other Grant/Funding Number)

Details and patient eligibility

About

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)

Full 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

Enrollment: 34 patients

Sex: Female

Ages: 24 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

EVERA

Experimental group

Description:

EVERA- korean ESTES system, apply for 12 weeks

Treatment:

Device: EVERA

ESTES

Active Comparator group

Description:

ESTES apply for 12 weeks

Treatment:

Device: ESTES