A Prospective Analysis of the Use of Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair as Long Term Follow Up to T-GENVIH-002 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinically Confirmed Recurrence
研究概览
简要总结
The T-GENVIH-003 study will collect additional, longer term performance data of Gentrix® Surgical Matrix used for reinforcement of ventral hernia repairs from a subset population (i.e., the twenty-one minimally invasive surgical approach cases) from the prior T-GENVIH-002 study.
详细描述
The purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs from a sub-population of twenty-one participants from the previous T-GENVIH-002 study, specifically those with laparoscopic or robotic repair. Prospective data will be collected via a one-off study follow-up visit and assessed for later post-operative surgical site events and complications in the post-operative period from the last timepoint of data collection in T-GENVIH-002 to present.
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
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient was a subject in the T-GENVIH-002 study and underwent minimally invasive (i.e., laparoscopic or robotic) abdominal wall reconstruction for a primary hernia using Integra® Gentrix® Surgical Matrix.
- •Subject has participated in the informed consent process and signed a study-specific informed consent document.
- •Subject is fluent in US English or US Spanish language.
- •Subject is willing to complete an e-consent and phone or in-office visit.
排除标准
- •Not applicable.
结局指标
主要结局
Number of Participants With Clinically Confirmed Recurrence
时间窗: Through study completion, an average of 4 months.
1. Incidence of clinically confirmed recurrence of the primary hernia to date, including not previously reported in T-GENVIH-002 study.
次要结局
- Self-Reported Recurrence(Through study completion, an average of 4 months.)
- Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention (SSOPI)(Through study completion, an average of 4 months.)
- Number of Participants With Surgical Site Occurrences (SSOs)(Through study completion, an average of 4 months.)
- Number of Subjects With Surgical Site Infections (SSIs)(Through study completion, an average of 4 months.)
- Number of Participants With Self-Reported Recurrence(Through study completion, an average of 4 months.)