NCT06664710招募中不适用
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Device Feasibility
研究概览
简要总结
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
详细描述
The purpose of this study is to evaluate the feasibility and proof of concept of the integration of the AIM System and iotaSOFT Insertion System during cochlear implantation. Study results will help inform the need for future clinical investigations and data collection in the area of ECochG and robotic-assisted cochlear implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cochlear implant candidate in one or two ears per current FDA indications
- •Sufficient residual hearing to support use of electrocochleography, as determined by the investigator
- •Cochlear implantation using the Advanced Bionics SlimJ electrode array
- •18 years of age or older at the time of enrollment
- •Willingness to participate in and comply with all requirements of the protocol
排除标准
- •Contraindications for a CI.
- •Prior cochlear implantation in the ear to be implanted.
- •Cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any other structural cochlear abnormality that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.
- •History of temporal bone fracture that involves the cochlea/internal auditory canal.
- •Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).
- •Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.
- •Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation.
- •Additional medical concerns that would prevent participation in evaluations as determined by the investigator.
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.
- •Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
结局指标
主要结局
Device Feasibility
时间窗: Procedure Day 0
Feasibility of device functionality intraoperatively at the time of cochlear implant surgery.
次要结局
未报告次要终点
研究者
研究点 (2)
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