Open-label, Multi-center Trial to Evaluate Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implants UNIGEL®
Not Applicable
Terminated
- Conditions
- Breast Augmentation
- Interventions
- Device: UNIGEL Silicone Gel-Filled Breast Implant
- Registration Number
- NCT02571751
- Lead Sponsor
- Sewoon Medical Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 69
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Breast Augmentation UNIGEL Silicone Gel-Filled Breast Implant -
- Primary Outcome Measures
Name Time Method a rate of capsular contracture of 10% 2 years a rate of rupture of 4% 2 years
- Secondary Outcome Measures
Name Time Method Change in nipple sensitivity 2 years Change in chest, bust and under bust circumference 2 years SF-36(Short Form (36) Health Survey ), Evaluation of quality of life 2 years Kaplan-Meier Analysis of rupture or capsular contracture events 2 years a rate of adverse evnets 2 years
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of