NCT04968457进行中（未招募）不适用
Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 908
- 主要终点
- Complication
研究概览
简要总结
The aim of the study is to allow Groupe SEBBIN to communicate to competent authorities and to the scientific community data relative to the safety and effectiveness of SEBBIN silicone gel-filled breast implants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The patient is at least 18-year-old.
- •The patient is genetically a woman.
- •The patient is candidate to a breast augmentation or breast reconstruction with silicone gel-filled breast implants.
- •The patient gets all information regarding the study and signs the informed consent relative to the use of her personal data.
排除标准
- •The patient is pregnant or breastfeeding.
- •The patient has silicone implants somewhere else than in the breast.
- •The patient was diagnosed with one of the following pathologies:
- •Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
- •Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
- •Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.
- •The patient has a pathology that could delay healing (does not apply to the reconstruction group).
- •The patient has cancer (does not apply to the reconstruction group).
- •The patient has anatomical or physiological conditions that could lead to postoperative complications.
结局指标
主要结局
Complication
时间窗: At 10 years of follow-up
complication rate
次要结局
未报告次要终点
研究者
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