NCT06936449招募中不适用
Long-term Follow-up of a Cohort of Adult CI632D and CI632 Participants in the CLTD5759 CI-DEX Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Cochlear
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) between groups obtained in the CLTD5759 (NCT04750642) study, and at the 2 through 5 years post-activation routine follow-up visits.
研究概览
简要总结
A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation.
- •Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642).
- •Willing and able to provide written informed consent.
排除标准
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the Investigator.
- •Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
- •Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator.
- •Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
研究组 & 干预措施
Experimental: CI632D Investigational Medical Device (IMD)
Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632D cochlear implant
干预措施: CI632D (Device)
Active Comparator: CI632 Comparator Device
Adults with bilateral postlinguistic sensorineural hearing loss, who have received the CI632 cochlear implant
干预措施: CI632 (Device)
结局指标
主要结局
Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) between groups obtained in the CLTD5759 (NCT04750642) study, and at the 2 through 5 years post-activation routine follow-up visits.
时间窗: 5 years post-activation
次要结局
- Comparison of CI632D and CI632 device-related adverse events between groups from enrolment in this study through 5 years postactivation.(5 years post-activation)
- Comparison of Four-point Impedance Measurement between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.(5 years post-activation)
- Comparison of low-frequency acoustic hearing between groups as measured by pure tone average thresholds over the range 125 through 500 Hz, obtained in the CLTD5759 (NCT04750642) study and from enrolment in this study through 5 years postactivation.(5 years post-activation)
- Comparison of speech perception in quiet (CNC word scores) for the best unilateral listening condition in the implanted ear between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.(5 years post-activation)
- Speech perception in noise (AzBio sentence scores) for the best bilateral listening condition obtained between groups in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.(5 years post-activation)
研究者
研究点 (4)
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