NCT02206282已完成不适用
Prevalence of Asymptomatic Rupture in SILIMED Breast Implants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 主要终点
- Magnetic Resonance Image
研究概览
简要总结
A prospective clinical research is to assess the prevalence of implant rupture and presence of extracapsular gel in an un-referred population of women who have been implanted with the Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject implanted with the original Silimed gel-filled implant.
排除标准
- •MR imaging is not possible because of the following:
- •Metal implant
- •Battery activated stimulator
- •Pregnancy
- •Body weight >300 pounds
- •History of metal fragments in the eye
- •Any other contraindication to MR exam.
结局指标
主要结局
Magnetic Resonance Image
时间窗: 1 year
390 Magnetic Resonance Images.
次要结局
未报告次要终点
研究者
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