Post-market Study of the Biodesign® Hernia Graft
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Hernia Recurrence
研究概览
简要总结
The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.
详细描述
This multicenter, open-label, prospective clinical study will evaluate the performance of the Biodesign Hernia Graft to reinforce soft tissues during ventral hernia repair.
This post-market study will enroll up to 95 patients at up to 10 clinical sites. Each clinical site will be limited to a maximum of 50 patients to ensure a variety of patients and surgical techniques are represented. There is no minimum enrollment number per site.
This study has been designed as a multicenter, open-label, prospective study to collect data on the performance of the Biodesign Hernia Graft. The inclusion and exclusion criteria for this study have been selected based on the instructions outlined in the IFU so that the results from this study can provide data on the real-world use of the device.
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
- 是
入选标准
- •1. Primary or recurrent ventral hernia in need of surgical repair utilizing a Biodesign Hernia Graft
排除标准
- •Known sensitivity to porcine material
- •For the study, the following patients will also be excluded:
- •Age < 18 years
- •Unable or unwilling to provide informed consent
- •Life expectancy of less than one year from the date of the index procedure
- •Patients will be excluded from the study if they never receive a Biodesign Hernia Graft during their index procedure.
结局指标
主要结局
Hernia Recurrence
时间窗: 1-year
Hernia recurrence through 1-year follow-up
次要结局
- Device-, Procedure-, and Hernia-related Adverse Event Rates(2-year)
- Hernia Recurrence Rate Through 2-year Follow-up(2-year)
- Operative Times(During operation)
- Hospital Stays for Serious Adverse Events(2-year)
- Hospitalization Times for Related Serious Adverse Events (SAEs)(From date of hospitalization for SAE. Patients were followed up to 2 years.)
- Patient-reported Quality of Life: Yes/No(2-year)
- Patient Reported Quality of Life-Pain Questions(2-year follow-up)
- Patient Reported Quality of Life-abdominal Wall(2-year follow-up)