NCT05642390终止不适用
Prospective Observational Study About SEBBIN Silicone Gel-filled INTEGRITY Mammary Implants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Complication rate
研究概览
简要总结
This study is part of the clinical evaluation of SEBBIN silicone gel-filled INTEGRITY implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.
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
- 否
入选标准
- •The patient is at least 18-year-old.
- •The patient is a woman.
- •The patient was prescribed with a surgery for a breast augmentation or reconstruction, unilaterally or bilaterally with silicone gel-filled SEBBIN INTEGRITY mammary implants.
- •The patient has been informed of the study, has read the patient information letter and provided consent in writing.
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.
- •History of implant-associated anaplastic large cell lymphoma (BIA-ALCL).
- •Symptomatic autoimmune 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 rate
时间窗: At 10 years of follow-up
次要结局
未报告次要终点
研究者
研究点 (1)
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