Pilot Evaluation of Combined Investigational Device: CI4CID With Controlled Dosage of Dexamethasone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Safety of Combined Device
研究概览
简要总结
In an effort to further preserve residual acoustic hearing after cochlear implantation, it may be beneficial to incorporate anti-inflammatory agents into the electrode array for passive elution over a time course after implantation. This study aims to assess the ease and effectiveness of such an electrode design, and to assess the preliminary safety of use of such a device in the post-operative period. This study is a first-time-in-human study of the investigational device.
In the first instance, the aim of the current investigation is to obtain first experience in use of a Combined Device in the adult clinical population, and to assess tools and techniques that may be considered in future clinical studies of similar devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration severe to profound hearing impairment in implanted ear of less than or equal to 30 years
- •Post-lingual hearing impairment defined as onset of hearing loss at greater than two years of age
- •Evidence of Pneumovax vaccination within three years of implantation date (for subjects to be implanted with the investigational device)
排除标准
- •Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or increased risk of infection (i.e. dysplastic cochlea), as confirmed by medical examination and imaging including MRI
- •Current use of grommets or evidence of tympanic membrane perforation
- •Known allergic reaction to dexamethasone or similar medicine
- •Diagnosis of Auditory Neuropathy
- •Active middle ear infection or history of middle ear infection within past two years
- •Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
- •Unwillingness or inability of the candidate to comply with all investigational requirements
- •Additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation
结局指标
主要结局
Safety of Combined Device
时间窗: Monitoring over 24 months
Monitoring of device related adverse events that occur during the study period, to assess the preliminary safety of the Combined Device
Surgical feedback
时间窗: During surgery
Questionnaire used to obtain surgical feedback from experienced cochlear implant surgeons regarding the electrode design, and ease and effectiveness of surgery, when using the Combined Device as compared to the Contour Advance electrode
次要结局
- Electrically evoked compound action potential (ECAP)(Testing over 24 months)
- Electrode impedance(Testing over 24 months)