WearLinq eWave Patch Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Wear Duration
研究概览
简要总结
This study it to evaluate the usability of the WearLinq eWave patch in a general adult population.
详细描述
Once eligibility is determined, participants will receive and apply the WearLinq patch for 7 consecutive days (or until an endpoint is met). A subset of subjects will be asked to participate in an Extended Use Cohort (30 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Adult >18 years old and able to consent
- •Capable of using a smartphone app
- •Willing to shave patch area if needed
排除标准
- •Planning to undergo an MRI during the study period
- •Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies, or any other dermatological conditional that could confound placement or results
- •Presence of pacemaker, ICD or other implanted electronic devices
- •Open wounds, lesions or infected or inflamed areas of skin at the placement site (left-center of chest/sternum)
- •Pregnant or intending to become pregnant during the course of the study
研究组 & 干预措施
7 Day Study
Participants will receive and apply the WearLinq patch for 7 consecutive days
干预措施: eWave Patch (Device)
Extended Use Cohort
Participants will receive and apply the WearLinq patch for 30 consecutive days
干预措施: eWave Patch (Device)
结局指标
主要结局
Wear Duration
时间窗: 7 Days
Days of use until one of the following is reached: patch no longer adheres, signal loss, voluntary removal, or 7 days is achieved
Adverse Events
时间窗: 7 Days
Incidences of self-reported adverse events for the duration of the study
次要结局
未报告次要终点