NCT04635228已完成不适用
Post-market Real-world Collection Data for the Biodesign® Otologic Repair Graft
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 10
- 主要终点
- Percent of closure
研究概览
简要总结
The post-market follow-up clinical trial of the Cook® Biodesign® Otologic Repair Graft will follow patients up to 3 months post-implantation to determine the percent of patients with complete closure of the tympanic membrane.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requires tympanic membrane closure.
排除标准
- •Life expectancy < 12 months
- •Known sensitivity to porcine material
结局指标
主要结局
Percent of closure
时间窗: 3 months
Percent of patients with complete closure of the tympanic membrane.
次要结局
未报告次要终点
研究者
研究点 (10)
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