Post-market Clinical Follow-up Study to Collect Safety, Performance and Clinical Data of the EZPass Suture Passer (Instrumentation) and Precision Flexible Reamers (Instrumentation)- A Retrospective Consecutive Series Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer)
研究概览
简要总结
The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.
详细描述
The primary objective of the study is to assess performance, clinical benefits and safety of the EZPass Suture Passer and the Precision Flexible Reamer Instrumentation.
Performance and clinical benefits will be assessed through an operative survey conducted immediately following intraoperative surgery to determine if the device performed as expected.
Safety will be assessed by recording and analyzing the incidence and frequency of complications, adverse events, and intra-operative revisions.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Performance of Instruments (EZ Pass Suture Passer and Precision Flexible Reamer)
时间窗: Intraoperative
Questionnaire was completed to assess if the Instrument Performed as Expected. Surgeon provided yes/no answers on their opinion if the instrument performed as expected during the procedure.
Absence of Instrument Related Serious Adverse Events
时间窗: Intraoperative
This outcome will measure the frequency of instrument related serious adverse events
次要结局
未报告次要终点