NCT04783883已完成不适用
Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Safety Assessment of Long-Term Usage
Neurovalens Ltd.1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年3月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Assessment of hearing function as reported by formal audiometry testing
研究概览
简要总结
A follow-up assessment study of the long-term safety of vestibular electrical stimulation as delivered by the Vestal DM Device.
详细描述
A retrospective, open-label, follow-up study assessing the long-term safety and efficacy of vestibular electrical stimulation as delivered by the Vestal DM Device.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Vestal DM user (more than 6 months)
排除标准
- •Vestal DM device user (less than 6 months)
结局指标
主要结局
Assessment of hearing function as reported by formal audiometry testing
时间窗: Baseline
Formal audiometry testing to be conducted using the AMTAS Flex Device
次要结局
- Frequency of device related adverse events(Baseline)
- Otoscope examination of the inside of both ear canals and tympanic membranes(Baseline)
- Inspection of the skin behind the ears (mastoid area)(Baseline)
研究者
研究点 (1)
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