NCT06101979Enrolling By Invitation不适用
A Prospective Study of Fortiva in Hernia Repair
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- RTI Surgical
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Type of adverse events
研究概览
简要总结
The goal of this study is to evaluate safety and performance of the Fortiva Tissue Matrix. Participants will complete questionnaires to measure outcomes after hernia surgery for two years.
详细描述
This is a post market, prospective, multi-center study of up to 120 participants at approximately 10 clinical study sites. Safety and performance will be measured after hernia repair for two years.
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
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age at time of consent
- •Undergoing hernia surgery in which Fortiva Tissue Matrix will be used
- •Have no contraindications to the test material (s)
- •Able to provide informed consent
- •Able to read, understand and complete study questionnaires
- •Able and willing to return for scheduled study visits
排除标准
- •<18 years of age
- •American Society of Anesthesiologists (ASA) physical class of 4,5 or 6
- •Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study
- •Hernia repairs involving active infection
结局指标
主要结局
Type of adverse events
时间窗: 6 weeks, 6 months, 12 months and 24 months
次要结局
- Hernia recurrence(12 months)
- Pain measured using the visual analog scale for pain(6 weeks, 6 months, 12 months and 24 months)
- Implant failure(6 weeks, 6 months, 12 months and 24 months)
- Patient satisfaction(6 weeks, 6 months, 12 months and 24 months)
研究者
研究点 (1)
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