NCT02571751
Terminated
Not Applicable
Open-label, Multi-center Trial to Evaluate Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implants UNIGEL®
Sewoon Medical Co., Ltd1 site in 1 country69 target enrollmentAugust 2015
ConditionsBreast Augmentation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Augmentation
- Sponsor
- Sewoon Medical Co., Ltd
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- a rate of capsular contracture of 10%
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
a rate of capsular contracture of 10%
Time Frame: 2 years
a rate of rupture of 4%
Time Frame: 2 years
Secondary Outcomes
- 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)
Study Sites (1)
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