NCT02392403已完成不适用
Clinical Investigation of the Nucleus® CI532 Cochlear Implant
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 45
- 试验地点
- 16
- 主要终点
- Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan
研究概览
简要总结
The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode design.
Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Eighteen years of age or older at the time of implantation
- •Conventional candidate for cochlear implantation with a perimodiolar electrode array according to local criteria (excepting the
排除标准
- •that follow)
- •Native speaker in the local language used to assess clinical performance
- •Exclusion Criteria:
- •Evidence of hearing loss prior to 5 years of age
- •Prior cochlear implantation; i.e. having a cochlear implant in the contralateral ear, or previously implanted in either ear
- •Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery
- •Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination
- •Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway
- •Active middle-ear infection
- •Tympanic membrane perforation
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices
- •Unwillingness or inability of the candidate to comply with all investigational requirements such as undergoing a post-operative digital volume tomography/ConeBeam scan
- •Patients with existing Cerebral Spinal Fluid shunts or drains, existing perilymph fistula, skull fracture or Cerebral Spinal Fluid leak
- •Patients with recurrent episodes of bacterial meningitis
- •Pregnancy or breast-feeding
- •Known allergies to components of the implant
- •Wearing other active implants with known interference with cochlear implants
研究组 & 干预措施
Nucleus CI532 cochlear implant
Experimental
干预措施: Nucleus CI532 cochlear implant (Device)
结局指标
主要结局
Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan
时间窗: up to one month post-surgery
The position of the electrode array can be completely in scala tympani, completely in scala vestibuli, or may transverse from scala tympani to scala vestibuli. The position can be determined from high resolution flat panel volume tomography (Cone beam) imaging.
次要结局
- Array Proximity to the Modiolus Measured Using the Wrapping Factor(up to one month post-surgery)
- Surgeon Questionnaire on Implant Surgery(at time of surgery)
- Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months(baseline and 6 months post activation)
- Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire(6 months post activation)
- Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months(baseline and 6 months post activation)
- Number of Adverse Events at Surgery(at time of surgery)
- Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months(baseline and 6 months post activation)
- Number of Adverse Events Post Surgery to 6 Months Post-activation(post surgery to 6 months post-activation)
研究者
研究点 (16)
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