NCT04968470招募中不适用
Prospective Observational Study About SEBBIN Silicone Gel-filled Testicular Implants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 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 testicular 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is an adult or a child at the time of implant placement with SEBBIN implant.
- •The patient is candidate to a unilateral or bilateral testicular implant placement with SEBBIN implant.
- •The patient has been informed of the study, has read the patient information letter and -provided oral consent.
排除标准
- •The patient has silicone implants somewhere else than in the scrotal sac.
- •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.
- •Custom-designed implants are used for surgery.
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 (2)
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