Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 42
- 试验地点
- 16
- 主要终点
- Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative
研究概览
简要总结
An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
详细描述
The primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone eluting electrode through reduction in electrode impedances as compared to a standard electrode and the improvement of speech recognition from preoperative baseline. The secondary objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as similar to a standard electrode by comparison of adverse events and speech outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL.
- •18 years or older at time of consent.
排除标准
- •Abnormal cochlear and middle ear anatomy
- •History with cochlear implant surgery
- •Allergy to dexamethasone
- •Women who are pregnant or plan to become pregnant
- •Unable/unwilling to comply to study requirements
结局指标
主要结局
Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) Between Randomization Groups at 6 Months Postoperative
时间窗: Six months postoperative
The impedance was measured across the active electrodes of the cochlear implant for each participant. Reduced impedances indicate less fibrotic obstruction caused by trauma associated with the electrode insertion.
Change in Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Compared to Pre-operative Baseline Measured at 6 Months Postoperative With CI632D
时间窗: Six months postoperative
Scores on the CNC Words in Quiet test were expressed as a percentage of words repeated correctly by the participant in a sound booth. A higher score indicates better speech perception performance. This outcome measure included the CI632D group only.
次要结局
- Comparison of Rate and Type of Device Related Adverse Events Between Randomization Groups(Twelve months postoperative)
- Comparison of Speech Perception Performance (Pre-recorded CNC Words in Quiet in Sound Booth Testing) Between the Randomization Groups at Six Months Postoperative(Six months postoperative)
- Comparison of Speech Perception Performance (AzBio Sentences in Quiet in Sound Booth Testing) Between Randomization Groups at Six Months Postoperative(Six months postoperative)