Breast Augmentation
Conditions
Brief 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.
Interventions
DEVICEUNIGEL Silicone Gel-Filled Breast Implant
Sponsors
Seoul National University Bundang Hospital
Samsung Medical Center
Sewoon Medical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a rate of rupture of 4% | 2 years |
| a rate of capsular contracture of 10% | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| a rate of adverse evnets | 2 years |
| Kaplan-Meier Analysis of rupture or capsular contracture events | 2 years |
| SF-36(Short Form (36) Health Survey ), Evaluation of quality of life | 2 years |
| Change in chest, bust and under bust circumference | 2 years |
| Change in nipple sensitivity | 2 years |
Countries
South Korea
Outcome results
None listed