A Multi-center Post-market Single Arm Prospective Study of Parietene™ DS Composite Mesh in Subjects Undergoing Ventral Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 12
- 主要终点
- Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair
研究概览
简要总结
A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months)
详细描述
A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months)
125 male or female adults subjects will be enrolled in a minimum of 4 USA sites who are undergoing elective ventral hernia repair (primary or incisional)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All subjects enrolled will receive the Parietene DS Composite Mesh
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
- •Preoperative Inclusion Criteria
- •Subject has provided informed consent
- •Subject is ≥18 years of age (at the time of consent)
- •Subject is undergoing elective ventral hernia repair (primary or incisional) with intraperitoneal mesh placement
排除标准
- •Preoperative Exclusion Criteria
- •BMI > 45 kg/m2
- •Subject is undergoing emergency surgery
- •Subject is pregnant or planning to become pregnant during study participation period
- •Subject is unable or unwilling to comply with the study requirements or follow-up schedule
- •Subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months
- •The subject has participated in another investigational drug or device research study within 30 days of enrollment
- •Subject has a parastomal hernia
- •Intra-operative Exclusion Criteria
- •Subject's hernia repair is in a contaminated or infected site (CDC wound class 2-4) as assessed by the Investigator(s)
- •Subject is undergoing "bridging" repair technique with the mesh placed in an "inlay" position
- •Surgeon is unable to completely remove existing mesh from prior surgery
- •Surgeon overlays 2 meshes
- •Subject receives any mesh other than Parietene™ DS composite mesh
结局指标
主要结局
Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair
时间窗: 12 months post surgery
次要结局
- Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair.(operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery)
- Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair(1 month, 3 months, and 24 months post-surgery)