NL-OMON31607已完成不适用
Stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation. - Long term evaluation of a novel baha fixture and abutment.
Cochlear BAS0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •The patient must meet the following criteria to be included;
- •Adult patients, i.e. >=18 years
- •Written informed consent
- •Eligible for the Baha system
- •Bone thickness at the implant site of at least 4 mm
- •Eligible for implantation with the two fixtures; 3,75 alternatively 4,5 mm wide
- •No known disease or treatment that compromises / will compromise the bone quality at the implant site
排除标准
- •The patient should meet none of the following criteria
- •Unable to follow investigational procedures
- •Simultaneous participation in another investigation with pharmaceuticals and/or devices
- •Any factor, at the discretion of the investigator that is considered to contraindicate participation.
研究者
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