Breast HypoplasiaNCT04185961
Pilot Study to Determine the Optimal Negative Pressure for Non-invasive Breast Augmentation in Women
A study testing EVERA-RAPHA with 60mmHG and EVERA-RAPHA with 100mmHG in people with Breast Hypoplasia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Aim is to investigate optimum pressure and evaluate safety and effectiveness of EVERA-RAPHA for breast augmentation Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Hypoplasia
- What is being tested?
- EVERA-RAPHA with 60mmHG and EVERA-RAPHA with 100mmHG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jan 2020to 6 Apr 2020
- 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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A woman over the age of twenty
- A woman who wants both breast enlargement
- A person whose difference between chest circumference and lower chest circumference is less than 10 cm.
- Subject who sign the consent form of the study and agree to participate in the clinical trial
- Subject who are willing and able to comply with study protocol
Who cannot join
- A woman who has a history of great weight-change
- A case that Breast cancer or mammary tumour found in basic physical examinations
- A woman with symptoms or history that suggest she has a fibroblastoma, breast pain, periodic congestion, etc.
- A woman with severe trauma around the breast.
- A woman with a scar or skin lesion around the breast.
- A woman with more than breast ptosis of Grade 3 (the nipple is less than 1-3 cm below the breast)
Show all 10Show fewer
- A woman with a history of chronic dermatitis, chronic pressure urticaria, contact dermatitis, etc.
- A woman who disagrees with contraception
- A woman who has previously undergone a breast reconstruction or breast augmentation
- A woman with an uncontrolled active infectious disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Univ. Bundang Hospital
Seongnam-si, Bundang,Gyeonggi-do, 463-707
About this study
Official title: A Double-blind Pilot Study to Determine the Optimal Negative Pressure of EVERA-RAPHA for Non-invasive Breast Augmentation in Women
Aim is to investigate optimum pressure and evaluate safety and effectiveness of EVERA-RAPHA for breast augmentation
Read the detailed description
- Subjects who voluntarily signed a consent form and met all inclusion / exclusion criteria should enroll in this study.
- Subjects enrolled in the study will be randomized and assigned to either Group1 or Group2 in a 1: 1 ratio.
- Apply EVERA RAPHA for 4 weeks
- Measure breast circumference and breast volume at Baseline and 4weeks later 4. Visit after 4 weeks to evaluate safety and effectiveness
- Conditions
- Breast Hypoplasia
- Being tested
- EVERA-RAPHA with 60mmHG, EVERA-RAPHA with 100mmHG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVERA-RAPHA with 60mmHGDevice
Apply EVERA-RAPHA with 60mmHG for 4weeks
EVERA-RAPHA with 100mmHGDevice
Apply EVERA-RAPHA with 100mmHG for 4weeks
| Study group | Role | What they receive |
|---|---|---|
| EVERA-RAPHA with 60mmHG | Experimental | EVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks Receives: Device: EVERA-RAPHA with 60mmHG |
| EVERA-RAPHA with 100mmHG | Experimental | EVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks Receives: Device: EVERA-RAPHA with 100mmHG |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the breast volume between before and after 4 weeks in test group 1 and test group 2 respectively.
change in the breast volume between before and after 4 weeks of wearing the medical device in test group 1 and test group 2 respectively.
Measured: Baseline and after 4 weeks
Secondary outcomes (3)
change in the breast circumference between before and after 4 weeks in test group 1 and test group 2 respectively.
change in the breast circumference between before and after 4 weeks of wearing the medical device in test group 1 and test group 2 respectively.
Measured: Baseline and after 4 weeks
difference the mean breast volume between test group 1 and test group 2
difference the mean breast volume between test group 1 and test group 2
Measured: Baseline and after 4 weeks
difference the mean breast circumference between test group 1 and test group 2
difference the mean breast circumference between test group 1 and test group
Measured: Baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start6 Jan 2020
- Primary completion30 Mar 2020
- Study completion6 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast HypoplasiaStudies 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
- Model description
- EVERA-RAPHA with 60 mmHg: EVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks EVERA-RAPHA with 100 mmHg: EVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chan Yeong Heo, Doctor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185961
- Sponsor's protocol ID
- GNSD_EVRP_2019
- Status last verified
- May 2020
- First submitted
- 1 Dec 2019
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Pilot Study to Determine the Optimal Negative Pressure of EVERA-RAPHA for Non-invasive Breast Augmentation in Women
- ClinicalTrials.gov ID
- NCT04185961
- Acronym / sponsor ID
- GNSD_EVRP_2019
- Conditions
- Breast Hypoplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 6 Apr 2020 (actual)
- First posted
- 4 Dec 2019 (actual)
- 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.
Aim is to investigate optimum pressure and evaluate safety and effectiveness of EVERA-RAPHA for breast augmentation
Detailed description
- Subjects who voluntarily signed a consent form and met all inclusion / exclusion criteria should enroll in this study.
- Subjects enrolled in the study will be randomized and assigned to either Group1 or Group2 in a 1: 1 ratio.
- Apply EVERA RAPHA for 4 weeks
- Measure breast circumference and breast volume at Baseline and 4weeks later 4. Visit after 4 weeks to evaluate safety and effectiveness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- EVERA-RAPHA with 60 mmHg: EVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks EVERA-RAPHA with 100 mmHg: EVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks
| Arm | Type | Receives |
|---|---|---|
| EVERA-RAPHA with 60mmHG | Experimental | Device: EVERA-RAPHA with 60mmHGEVERA-RAPHA apply 15 minutes with 60mmHG every day for 4 weeks |
| EVERA-RAPHA with 100mmHG | Experimental | Device: EVERA-RAPHA with 100mmHGEVERA-RAPHA apply 15 minutes with 100mmHG every day for 4 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A woman over the age of twenty
- A woman who wants both breast enlargement
- A person whose difference between chest circumference and lower chest circumference is less than 10 cm.
- Subject who sign the consent form of the study and agree to participate in the clinical trial
- Subject who are willing and able to comply with study protocol
Key exclusion criteria (10 listed)
- A woman who has a history of great weight-change
- A case that Breast cancer or mammary tumour found in basic physical examinations
- A woman with symptoms or history that suggest she has a fibroblastoma, breast pain, periodic congestion, etc.
- A woman with severe trauma around the breast.
- A woman with a scar or skin lesion around the breast.
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 |
|---|---|---|
| EVERA-RAPHA with 60mmHGApply EVERA-RAPHA with 60mmHG for 4weeks | Device | EVERA-RAPHA with 60mmHG |
| EVERA-RAPHA with 100mmHGApply EVERA-RAPHA with 100mmHG for 4weeks | Device | EVERA-RAPHA with 100mmHG |
Primary outcome
change in the breast volume between before and after 4 weeks in test group 1 and test group 2 respectively.
Time frame: Baseline and after 4 weeks
change in the breast volume between before and after 4 weeks of wearing the medical device in test group 1 and test group 2 respectively.
3 secondary outcomes
change in the breast circumference between before and after 4 weeks in test group 1 and test group 2 respectively.
Time frame: Baseline and after 4 weeks
difference the mean breast volume between test group 1 and test group 2
Time frame: Baseline and after 4 weeks
difference the mean breast circumference between test group 1 and test group 2
Time frame: Baseline and after 4 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 20 May 2020.
- Individual participant dataSharing planned: No
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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.
Chan Yeong Heo, Doctor 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-RAPHA with 60mmHG and EVERA-RAPHA with 100mmHG in people with Breast Hypoplasia, 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 10 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 20 May 2020. 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?
change in the breast volume between before and after 4 weeks in test group 1 and test group 2 respectively. (time frame: Baseline and after 4 weeks). 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 20 May 2020.