A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis in Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RTI Surgical
- 入组人数
- 87
- 试验地点
- 6
- 主要终点
- Safety of Fortiva® tissue matrix
研究概览
简要总结
This is a post market prospective, multi-center study of up to 100 subjects undergoing post-mastectomy breast reconstruction (50 Fortiva® 1mm perforated and 50 Fortiva® 1mm non-perforated) at up to 10 clinical study sites in Europe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female 18 years or older
- •A candidate for immediate breast reconstruction during post-skin sparing or nipple-sparing mastectomy (unilateral or bilateral)
- •Estimated life expectancy > 2 years
- •Able and willing to return for all scheduled and required study visits
- •Able to provide written informed consent for study participation
- •Able to read, understand and complete study questionnaires
排除标准
- •Any of the conditions listed in the approved labeling as contraindicated
- •Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study
- •Any patient that per the physician's judgement is not a good candidate for this study
研究组 & 干预措施
Perforated
Fortiva® 1mm perforated ADM
干预措施: Fortiva® 1mm (Device)
Non-perforated
Fortiva® 1mm non-perforated ADM
干预措施: Fortiva® 1mm (Device)
结局指标
主要结局
Safety of Fortiva® tissue matrix
时间窗: 24 months
Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events.
Performance of Fortiva® tissue matrix
时间窗: 24 months
• Analysis of the subject's overall satisfaction with the breast reconstruction procedure will be assessed by obtaining subject's perception of the outcomes using the Breast-QTM - Reconstruction survey.
次要结局
未报告次要终点