Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants With Smooth Surface (STEPS S)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Unexpected Adverse Events
研究概览
简要总结
The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years. The safety of the smooth-surfaced Silimed® implant will be evaluated by estimating known and unexpected short-term and long-term risk/adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand smooth surface breast implants will be evaluated by evaluating satisfaction and quality of life after implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Provide written informed consent
- •Female at birth
- •Be 18 years of age or older
- •Have a complaint of hypomastia
- •Have an indication for breast augmentation with silicone implants
- •Ability to comply with the protocol throughout the follow-up period.
排除标准
- •Replacement of breast implants due to a complication
- •Breast reconstruction in at least one breast
- •Informed pregnancy or breastfeeding at the time of inclusion
- •Sequelae of mastopexy
- •Ptosis requiring mastopexy
- •Breast changes or lumps rated BI-RADS 3 or higher on preoperative ultrasound or mammograms
- •Advanced fibrocystic disease at the time of implantation
- •Neoplasia of any type not yet treated or undergoing treatment at the time of implantation, - Active infection not yet treated or undergoing treatment at any site at the time of implantation
- •Report or record of adverse reactions or intolerance to silicone prior to implantation
- •Report or record of immune diseases affecting the active or undergoing treatment (e.g. lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation
- •Signs of inflammation of the breast or implant site at the time of implantation
- •Increased risk of post-implantation complications -immediate surgical complications caused by illicit drug use or medication use
- •Having participated in another clinical trial within 6 months prior to implant placement
- •Any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, make study participation unsafe, compromise protocol adherence, complicate the interpretation of study outcome data, or otherwise interfere with the achievement of study objectives
研究组 & 干预措施
primary augmentation group
Women undergoing primary breast augmentation with Silimed® smooth surface Breast Implant.
secondary (revision) augmentation group
Women undergoing secundary or revision breast augmentation with Silimed® smooth surface Breast Implant.
结局指标
主要结局
Unexpected Adverse Events
时间窗: Every three years over the 10-year duration of the study
Estimate the unknown short-term and long-term risk / adverse event rate for breast implant with smooth surface Silimed®
Expected Adverse Events
时间窗: Every three years over the 10-year duration of the study
Estimate the known short-term and long-term risk / adverse event rate for breast implant with smooth surface Silimed®
次要结局
- Patient's Satisfaction in General(Every three years over the 10-year duration of the study)
- Patient's Satisfaction in Relation to Aesthetic Result(Every three years over the 10-year duration of the study)
- Evaluator's Satisfaction in Relation to Aesthetic Result(Every three years over the 10-year duration of the study)
- Patient's Quality of Life(Every three years over the 10-year duration of the study)