NCT07256951招募中不适用
Gen 2 Battrode Wear Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 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.
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 (2)
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