NCT02132572已完成不适用
Retrospective Multi-centre, Post-marketing Study to Evaluate the Incidence and Aetiology of Reoperations With Allergan Natrelle® Breast Implants in Primary Augmentation (RANBI)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 201
- 主要终点
- Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant
研究概览
简要总结
Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary breast augmentation (either bilateral or unilateral) operated on by the investigating surgeon with an infra-mammary approach 410 cohesive BIOCELL™ textured device (Truform 2 & 3 only) has been implanted
- •Primary breast augmentation 3 to 10 years prior to data collection
- •Submuscular/dual plane or subglandular implant placement
排除标准
- •Breast augmentation for Poland Syndrome or amastia
- •Breast reconstruction following mastectomy
- •Revision or secondary breast reconstruction
- •Non 410 device at initial breast augmentation
- •Women subsequently diagnosed with fibrocystic disease considered to be pre-malignant
- •Procedures of the breast not related to the primary breast augmentation (e.g. excision of skin lesions)
- •Axillary or peri-areolar approach
- •Glandular mastopexy augmentation (skin excision only)
结局指标
主要结局
Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant
时间窗: 3 to 10 years
Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant.
次要结局
未报告次要终点
研究者
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