Middle East MED-EL Observatory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Hearing threshold level
研究概览
简要总结
In the field of cochlear implant research, there are only few data on long-term observational studies available to gain knowledge on clinical effectiveness. Longitudinal comparisons of data collected in different clinics is challenging due to the heterogeneity in measures and procedure.
This Registry represents a non-interventional systematic collection of clinical data in which prospective data from children and adults are collected as anonymized data sets, derived from original clinical records on appropriately informed subjects. Each subject will be treated as per clinical routine.
The Registry will be implemented through a secure, cloud-based, platform that enables collection of anonymized data at consistent time intervals, thus enabling the comparison of repeated measures over time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are implanted or will be implanted with a MED-EL CI system.
- •Signed written informed consent for data collection for registry purposes.
排除标准
- •Lack of compliance with any inclusion criteria.
- •Subjects not receiving a MED-EL CI system due to medical or personal reasons after having consented.
- •Anything that, in the opinion of the Investigator would place the subject at increased risk or preclude the subject's full compliance with or completion of the registry procedures.
结局指标
主要结局
Hearing threshold level
时间窗: 5 years
Audiometry testing (unaided)
Quality of hearing - adults
时间窗: 5 years
Results from the Hearing Implant Sound Quality Index (HISQUI 19)
Auditory development - children (CAP)
时间窗: 5 years
Results from the Categories of Auditory Performance (CAP)
Auditory development - children (SIR)
时间窗: 5 years
Results from the Speech Intelligibility Rating (SIR)
Auditory development - children (LEAQ)
时间窗: 5 years
Results from the LittlEARS Auditory Questionnaire (LEAQ)
次要结局
未报告次要终点