PMEI Post-Market Clinical Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 497
- 试验地点
- 11
- 主要终点
- ABG
研究概览
简要总结
Confirm safety and performance of passive middle ear implants (PMEIs) in subjects with pre-existing condition which made the implantation of a MED-EL PMEI necessary
详细描述
Collect retrospective audiological and safety results of PMEI implanted subjects. A post-operative minimum and maximum follow-up period was not defined. The mean of the post-operative follow-up period of all patients was calculated.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implanted with a MED-EL PMEI; initial implantation or revision implantation receiving a MED-EL PMEI
排除标准
- 未提供
结局指标
主要结局
ABG
时间窗: A post-operative minimum and maximum follow-up period was not defined.
To collect post-operative PTA4 ABG results. It was expected to achieve a post-operative ABG ≤ 20 dB with a PMEI, by at least 25 % of the total ossicular replacement prostheses patients, by at least 53.8 % of the partial ossicular replacement prostheses patients, and by at least 86 % of the stapes prostheses patients.
次要结局
- adverse events(A post-operative minimum and maximum follow-up period was not defined.)