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临床试验/NCT02200523
NCT02200523已完成不适用

Self Abrading Rapidly Applied (SARA) Electrode Phase II

Cleveland Medical Devices Inc2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年6月1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
40
试验地点
2
主要终点
Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode

研究概览

简要总结

The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining multiple steps that burden conventional EEG procedures into one. The investigators believe that the proposed system will reduce patient hookup time by more than 50% (from 40 to 20 minutes) with additional time savings on cleanup. Reducing the hookup time required for the EEG recording will make EEG more feasible in time critical situations and will improve patient care and service. The clinical testing in Phase II will investigate patient acceptance, clinician acceptance, time savings, and signal quality for 3 different environments: the large hospital institution, a small rural hospital setting and in an emergency department.

详细描述

The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining multiple steps that burden conventional EEG procedures into one. This proposed single-use electrode will consist of a Snap Top, Ag/AgCl Snap Conductor, Conductive Adhesive, and Abrader Tines in a custom molded housing and packed on a backing sheet. After removing the backing, the technician simply parts the hair with one hand and with the other hand rubs the electrode back and forth and then presses the electrode into position on the scalp. The proposed system combines the cumbersome and time-consuming skin preparation, electrode preparation and electrode fixation into one easy step. The investigators believe that the proposed system will reduce patient hookup time by more than 50% (from 40 to 20 minutes) with additional time savings on cleanup. Reducing the hookup time required for the EEG recording will make EEG more feasible in time critical situations and will improve patient care and service.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

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

入选标准

  • adult and teenage

排除标准

  • young children
  • damaged scalp skin
  • sensitive or allergic to electrode paste

结局指标

主要结局

Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode

时间窗: up to 1 hour

The time it takes in seconds to properly place the SARA electrodes and standard gold cup electrodes will be recorded and compared.

次要结局

未报告次要终点

研究者

发起方
Cleveland Medical Devices Inc
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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