Efficacy and Safety Study of EVERA to Augment Small Breast | NCT02009137

Studies
Efficacy and Safety Study of EVERA to Augment Small Breast

NCT02009137

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Mar 5, 2015Estimated

Enrollment

34Actual

Phase

Not Applicable

Conditions

Atrophy of Breast

Interventions

EVERA
ESTES

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
06-2013-175-GNSD	Other Grant/Funding Number	GNSD Co.,Ltd

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Jul 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Dec 6, 2013

First Submission Date that Met QC Criteria

Dec 6, 2013

First Posted Date

Dec 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2015

Last Update Posted Date

Mar 5, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chan-Yeong Heo, Assistant Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EVERA	Experimental	EVERA- korean ESTES system, apply for 12 weeks	Device: EVERA
ESTES	Active Comparator	ESTES apply for 12 weeks	Device: ESTES

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EVERA	Device	EVERA apply for 12 weeks	EVERA
ESTES

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change in breast volume of the test group and control group		Baseline and 12weeks and 16weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in satisfaction level on their breast		Baseline and 12weeks and 16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chanyeong - Heo, Ph.D	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National Univ. Bundang Hospital		Seongnam-si	Gumi-dong, Bundang-gu/Gyeonggi-do	463-707	South Korea