NCT07256951已完成不适用
Gen 2 Battrode Wear Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Wear time
研究概览
简要总结
Validating adhesive wear time
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- •Participant is ≥ 18 years.
- •Completes the consent process as required.
- •Participants can speak and read English fluently.
- •Willing to allow shaving of device application area, as required.
- •Willing to take photos of the application area before wear, daily during wear, and immediately after removal.
- •Willingness to report current known pregnancy.
排除标准
- •Unable to comply with the study protocol and instructions for wearing the devices for up to 15 days.
- •Any pre-existing breached or compromised skin, skin rash, irritation or infection at the application area.
- •Any incision, wound or scar in the application area.
- •Participants with known skin allergies and sensitivities to adhesives.
- •Participants with scheduled electronic imaging (including magnetic resonance imaging), cardioversion, and/or procedures where device would be removed during the data collection period.
- •Participants with known history of cardiac arrhythmias.
- •Participants with chest anatomies not compatible with secure parasternal placement.
- •Use of clothing or garment that can dislodge or loosen the patch or bras with underwires or other worn items that might interfere with the devices under study.
研究组 & 干预措施
adhesive one
Experimental
干预措施: Adhesive (Device)
Adhesive two
Experimental
干预措施: Adhesive (Device)
结局指标
主要结局
Wear time
时间窗: 15 days
次要结局
未报告次要终点
研究者
研究点 (1)
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