Breast AugmentationNCT02571751
Open-label, Multi-center Trial to Evaluate Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implants UNIGEL®
A study testing UNIGEL Silicone Gel-Filled Breast Implant in people with Breast Augmentation, run by Sewoon Medical Co., Ltd at 1 site in South Korea.
Trial summary
Open-label, Multi-center, Clinical trial to Evaluate Safety and Efficacy of Cohesive Gel-Filled Breast Implants UNIGEL® Targeting of Women from 22 to 60 Aged with regard to Augmentation Mammaplasty for Purpose of Cosmetic Surgery. Read more about this study
- Who is it for?
- Ages 22 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Augmentation
- What is being tested?
- UNIGEL Silicone Gel-Filled Breast Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to 23 Apr 2021
- 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 22 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has given written informed consent to entry
- Female, 22 years to 60 years
- Breast augmentation(cosmetic surgery) is for following subjects
- Who is not content with breast size and shape
- Who has congenital asymmetrical deformity
- subject who agree to MRI scan during the trial
- subject who agree to visit to hospital according to schedule specified in the protocol during the entire period of the trial
Who cannot join
- Pregnant or lactating women and women of childbearing age
- Subject who has operation history of breast augmentation or reconstruction
- Subject who has fibrocystic Breast Disease coming up for precancerous lesion not accompanied with subcutaneous mastectomy
- Subject who has breast cancer or prodromal phase and no proper treatment.
- Subject who is diagnosed with Breast Imaging-Reporting and Data System(BI-RADS) category 3 under breast ultrasonography.
- Subject who has uncontrolled active infectious disease or abscess
Show all 14Show fewer
- Autoimmune disease
- Diabetes mellitus
- Keloidosis
- Subject who cannot take general anesthesia due to abnormal blood or ECG results.
- Subject who is not appropriate for breast augmentation due to damaged tissue or blood vessel or ulcer
- Subject who has metal materials in a body such as ventricular assist system or cerebral aneurysm clips, or has claustrophobia (not suitable for MRI SCAN)
- Physically/mentally disabled subject that may disturb understanding and cooperation for the trial.
- Any other conditions that may interfere with correct assessment of the trial.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
About this study
Open-label, Multi-center, Clinical trial to Evaluate Safety and Efficacy of Cohesive Gel-Filled Breast Implants UNIGEL® Targeting of Women from 22 to 60 Aged with regard to Augmentation Mammaplasty for Purpose of Cosmetic Surgery.
- Conditions
- Breast Augmentation
- Being tested
- UNIGEL Silicone Gel-Filled Breast Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNIGEL Silicone Gel-Filled Breast ImplantDevice
| Study group | Role | What they receive |
|---|---|---|
| Breast Augmentation | Experimental | Not described Receives: Device: UNIGEL Silicone Gel-Filled Breast Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
a rate of rupture of 4%
Measured: 2 years
a rate of capsular contracture of 10%
Measured: 2 years
Secondary outcomes (5)
Kaplan-Meier Analysis of rupture or capsular contracture events
Measured: 2 years
Change in nipple sensitivity
Measured: 2 years
a rate of adverse evnets
Measured: 2 years
Change in chest, bust and under bust circumference
Measured: 2 years
SF-36(Short Form (36) Health Survey ), Evaluation of quality of life
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startAug 2015
- Primary completion23 Apr 2021
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AugmentationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sewoon Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571751
- Sponsor's protocol ID
- Protocol Approval No. 534
- Status last verified
- Sep 2021
- First submitted
- 6 Oct 2015
- Last updated
- 28 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multi-center Trial to Evaluate Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implants UNIGEL®
- ClinicalTrials.gov ID
- NCT02571751
- Acronym / sponsor ID
- Protocol Approval No. 534
- Conditions
- Breast Augmentation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Sewoon Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Bundang Hospital, Samsung Medical Center
- Study start
- Aug 2015 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 8 Oct 2015 (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.
Open-label, Multi-center, Clinical trial to Evaluate Safety and Efficacy of Cohesive Gel-Filled Breast Implants UNIGEL® Targeting of Women from 22 to 60 Aged with regard to Augmentation Mammaplasty for Purpose of Cosmetic Surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Augmentation | Experimental | Device: UNIGEL Silicone Gel-Filled Breast Implant |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Has given written informed consent to entry
- Female, 22 years to 60 years
- Breast augmentation(cosmetic surgery) is for following subjects
- subject who agree to MRI scan during the trial
- subject who agree to visit to hospital according to schedule specified in the protocol during the entire period of the trial
Key exclusion criteria (14 listed)
- Pregnant or lactating women and women of childbearing age
- Subject who has operation history of breast augmentation or reconstruction
- Subject who has fibrocystic Breast Disease coming up for precancerous lesion not accompanied with subcutaneous mastectomy
- Subject who has breast cancer or prodromal phase and no proper treatment.
- Subject who is diagnosed with Breast Imaging-Reporting and Data System(BI-RADS) category 3 under breast ultrasonography.
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 |
|---|---|---|
| UNIGEL Silicone Gel-Filled Breast Implant | Device | Breast Augmentation |
Primary outcome
a rate of rupture of 4%
Time frame: 2 years
a rate of capsular contracture of 10%
Time frame: 2 years
5 secondary outcomes
Kaplan-Meier Analysis of rupture or capsular contracture events
Time frame: 2 years
Change in nipple sensitivity
Time frame: 2 years
a rate of adverse evnets
Time frame: 2 years
Change in chest, bust and under bust circumference
Time frame: 2 years
SF-36(Short Form (36) Health Survey ), Evaluation of quality of life
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UNIGEL Silicone Gel-Filled Breast Implant in people with Breast Augmentation, run by Sewoon Medical Co., Ltd 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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 28 Sep 2021. 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 was stopped early. Results are not available in the source record.
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?
a rate of rupture of 4% (time frame: 2 years). The study lists 2 primary outcomes in all. 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 28 Sep 2021.