NCT03904420终止不适用
An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cochlear
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Change in Time Spent With Audiologist
研究概览
简要总结
The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients who are receiving a Nucleus® CI512, CI522, or CI532 electrodes
- •18 years and older
- •Postlingual onset of hearing loss (onset of hearing loss >two years of age)
- •Individuals who qualify for cochlear implantation using the clinics current CI candidacy criteria
- •Individuals who have recently been implanted but not yet had their external device activated
- •Willingness to participate in a study and comply with all study requirements
- •Fluent in spoken English
排除标准
- •Ossification or any other cochlear anomaly that might prevent insertion of less than 10 electrodes of the electrode array
- •Diagnosis of retro-cochlear pathology
- •Diagnosis of auditory neuropathy
- •Subject considering an acoustic component in the implanted ear
- •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 to comply with all investigational requirements
- •Severe-profound sensorineural hearing loss >30 years
- •Previous cochlear implant in the contralateral ear. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the investigator
结局指标
主要结局
Change in Time Spent With Audiologist
时间窗: 6 months post activation
Change in the overall number of minutes of cochlear implant appointments over the first 6 months post activation in the new model (Group A) compared to the traditional model (Group B).
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Evaluating a new model of care to enable patients to manage their medicinesProblems with medicinesNonadherence/noncompliance with prescribed medicinesISRCTN41824121HS R&D Regional Programme Register - Department of Health (UK)
已完成
不适用
Implementation of a model of care for acute low back pain in emergency departmentsAcute low back painAcute exacerbation of chronic low back painMusculoskeletal - Other muscular and skeletal disordersACTRN12617001160325The University of Sydney4,824
已完成
不适用
Evidence-based Algorithm for the Expected Difficult IntubationAirway ManagementIntubation, IntratrachealNCT04863846Universitätsklinikum Hamburg-Eppendorf1,282
已完成
不适用
Alberta Hip and Knee Replacement ProjectArthroplasty, Replacement, HipArthroplasty, Replacement, KneeNCT00277186Alberta Bone and Joint Health Institute3,434
已完成
不适用
Observational Study for Patients With Newly Diagnosed (MCL) Not Eligible for High-dose TherapyMantle Cell LymphomaNCT03054883Czech Lymphoma Study Group73