NCT01426477终止不适用
Veritas in Non-Bridging Ventral Hernia Repair
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Hernia recurrence
研究概览
简要总结
The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.
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
- •Must be 18 years of age or older
- •Ability to understand and read English
- •Must be scheduled for open abdominal surgery for repair of primary ventral hernia or first recurrence of a ventral hernia with the Veritas Collagen Matrix using the underlay technique, with our without component separation
- •Must be of ambulatory status
- •Primary closure can be obtained during surgery
- •Repair is such that one piece of Veritas can be used to reinforce the repair
排除标准
- •Hernia is undetectable on physical exam
- •There is evidence of existing cancer
- •Use of chronic immunosuppressive therapy, including steroids or cytotoxic agents
- •Any condition that product labeling indicates would adversely affect participant safety, including sensitivity to bovine products
结局指标
主要结局
Hernia recurrence
时间窗: 2 Years
Recurrence will be evaluated through physical exam and/or CT scans at all study visits (30 days, 6 months, 1 year, and 2 years), or when patients present with symptoms, with primary endpoint at 2 years.
次要结局
- Number of Medical and Surgical Complications(2 years)
- Change in Quality of Life(Baseline to 2 Years)
研究者
研究点 (4)
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