NCT00866814已完成不适用
A Prospective, Single Arm, Multi-Center Study Of Open Ventral Hernia Repair Utilizing The Bard Ventrio Hernia Patch
C. R. Bard7 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2009年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 7
- 主要终点
- The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.
研究概览
简要总结
This study will collect data on patients undergoing hernia repair using the Bard Ventrio Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of life and complications associated with the device and surgical procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male or female, age ≥ 18
- •Be able to undergo study procedures
- •Have signed an Informed Consent form (ICF)
- •Be diagnosed with a ventral hernia requiring an open surgery for repair.
排除标准
- •Patient is participating in another device or drug study.
- •Patient exhibits clinical symptoms indicating infected hernia site.
- •Patient currently has a clean contaminated or contaminated site.
- •Patient has a life expectancy less than 2 years at the time of enrollment.
- •Anything in the opinion of the Investigator that would preclude the use of the Ventrio Hernia Patch, or preclude the subject from completing the follow-up requirements.
结局指标
主要结局
The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.
时间窗: 1 year post surgery
A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure.
次要结局
- Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital.(From the time of surgery to hospital discharge, an average of 1-2 days)
- Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure.(Hospital discharge through 21 days post surgery)
- Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year.(22 days post surgery through 1 year post surgery)
- Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey(Baseline and post-surgery at week 2, month 6 and month 12)
- Procedure Time(Day of surgery)
研究者
研究点 (7)
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