NCT02438332已完成不适用
Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants
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
- 330
- 试验地点
- 17
- 主要终点
- Incidence of Reoperations of All Cause Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 Breast Implants
研究概览
简要总结
This study will evaluate the incidence of reoperations associated with the use of smooth and textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone primary breast augmentation.
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
- 22 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 smooth or textured NATRELLE® INSPIRA® TruForm® 1 or 2 device
- •Primary breast augmentation 2 to 4 years (24-48 months) prior to data collection
- •Subfascial, 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 NATRELLE® INSPIRA® device implanted at initial breast augmentation
- •Women diagnosed with breast disease considered to be pre-malignant or malignant prior to or at the time of primary breast augmentation
- •Surgical procedures of the breast not related to the primary breast augmentation (e.g. excision of significant skin lesions or a biopsy) occurring prior to or at the time of primary augmentation that may adversely affect the aesthetic outcome in the opinion of the investigator
- •Axillary or peri-areolar approach
- •Mastopexy augmentation
结局指标
主要结局
Incidence of Reoperations of All Cause Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm® 1 or TruForm® 2 Breast Implants
时间窗: 4 Years
次要结局
- Incidences of Implant Removal With Replacement(4 Years)
- Incidence (by Product Type) of First Reoperation Following the Use of Smooth or Textured NATRELLE® INSPIRA® TruForm®1 or TruForm® 2 Breast Implants(4 Years)
- Reasons For Primary Augmentation(4 Years)
- Reasons For Reoperation Incidence(4 Years)
- Time From the Date of Implant Until First Reoperation(4 Years)
- Incidences of Implant Removal Without Replacement(4 Years)
研究者
研究点 (17)
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