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临床试验/NCT07161154
NCT07161154尚未招募不适用

Sentio Systematic Evaluation - SENSE

Oticon Medical0 个研究点目标入组 100 人开始时间: 2025年9月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Rate of succesful use of the device
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The study is designed as an international, multi-center, single-armed, non-interventional/observational study including subjects who has received or are planned to receive the Sentio system as part of normal clinical practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Subject who is scheduled for or have undergone Sentio implantation in clinical practice.
  • •Subject who has consented to participation or are covered by consent waiver.

排除标准

  • •Subjects enrolled in other clinical investigations leading to their Sentio implantation and subsequent follow-up deviating substantially from clinical practice

结局指标

主要结局

Rate of succesful use of the device

时间窗: Completion of the surgical procedure is reported at the surgery. Device specific questionnaire is typically completed within the first year of follow-up, though timing may vary depending on local practice for follow-up.

Successful use is defined as a composite outcome consisting of completion of the surgical procedure and patient reported satisfaction after fitting and use of the device (assessed through a device specific questionnaire).

次要结局

  • Frequency of surgical events and complications(During surgery)
  • Assess surgical approaches and techniques(During surgery)
  • Frequency of post-operative complications(From surgery till end of follow-up (expected up to 10 years))
  • Timing of fitting(During fitting appointment (typically 2-15 weeks after surgery, depending on patient needs and local variations on practice))
  • To assess improvement in hearing(At fitting and throughout follow-up period (expected up to 10 years))

研究者

申办方类型
Industry
责任方
Sponsor

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