Atrophy of BreastNCT02009137
Efficacy and Safety Study of EVERA to Augment Small Breast
A study testing EVERA and ESTES in people with Atrophy of Breast, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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) Read more about this study
- Who is it for?
- Ages 24 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atrophy of Breast
- What is being tested?
- EVERA and ESTES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnant or Lactating subjects
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Univ. Bundang Hospital
Seongnam-si, Gumi-dong, Bundang-gu/Gyeonggi-do, 463-707
About this study
Official 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
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)
Read the 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
- Conditions
- Atrophy of Breast
- Being tested
- EVERA, ESTES
- Keywords
- small breast, augmentation, breast volume, External Soft Tissue Expansion System(ESTES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVERADevice
EVERA apply for 12 weeks
ESTESDevice
ESTES apply for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| EVERA | Experimental | EVERA- korean ESTES system, apply for 12 weeks Receives: Device: EVERA |
| ESTES | Active comparator | ESTES apply for 12 weeks Receives: Device: ESTES |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in breast volume of the test group and control group
Measured: Baseline and 12weeks and 16weeks
Secondary outcomes (1)
Changes in satisfaction level on their breast
Measured: Baseline and 12weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophy of BreastStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan-Yeong Heo, Seoul National University Hospital
- Investigators
- Chanyeong - Heo, Ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009137
- Sponsor's protocol ID
- E1307-210-002
- Other IDs
- 06-2013-175-GNSD
- Status last verified
- Mar 2015
- First submitted
- 6 Dec 2013
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02009137
- Acronym / sponsor ID
- E1307-210-002
- Conditions
- Atrophy of Breast
- Keywords
- small breast, augmentation, breast volume, External Soft Tissue Expansion System(ESTES)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVERA | Experimental | Device: EVERAEVERA- korean ESTES system, apply for 12 weeks |
| ESTES | Active comparator | Device: ESTESESTES apply for 12 weeks |
Who may qualify
- Ages
- 24 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant or Lactating subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVERAEVERA apply for 12 weeks | Device | EVERA |
| ESTESESTES apply for 12 weeks | Device | ESTES |
Primary outcome
The change in breast volume of the test group and control group
Time frame: Baseline and 12weeks and 16weeks
1 secondary outcome
Changes in satisfaction level on their breast
Time frame: Baseline and 12weeks and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
Related trials for Atrophy of Breast
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
Vaginal Atrophy, Breast Carcinoma
Recruiting
Multicomponent Prehabilitation in Older Adults With Breast Cancer
Breast Cancer, Frailty
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chanyeong - Heo, Ph.D principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVERA and ESTES in people with Atrophy of Breast, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in breast volume of the test group and control group (time frame: Baseline and 12weeks and 16weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.