NCT03180749进行中（未招募）不适用
Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome Between Devices With Subcomponents From Two Different Suppliers
Intrinsic Therapeutics6 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2017年3月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Device failures
研究概览
简要总结
Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome between Devices with Subcomponents from Two Different Suppliers
详细描述
Comparison of device integrity (anchor fracture and/or mesh detachment) and device movement/migration in patients implanted with the Barricaids with anchors from two different suppliers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each site will enroll all patients who were implanted with a Barricaid with an anchor manufactured by the second manufacturer.
- •Patients must be 18 years of age or older and able to understand and consent to participate in the study.
排除标准
- •Not defined
结局指标
主要结局
Device failures
时间窗: 22+ months post implantation
Device failures and movement/migration will be assessed by a radiographic core laboratory.
次要结局
未报告次要终点
研究者
研究点 (6)
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