NCT02571751终止不适用
Open-label, Multi-center Trial to Evaluate Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implants UNIGEL®
Sewoon Medical Co., Ltd1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2015年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- a rate of capsular contracture of 10%
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
a rate of capsular contracture of 10%
时间窗: 2 years
a rate of rupture of 4%
时间窗: 2 years
次要结局
- 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)
研究者
研究点 (1)
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