NCT04064229已完成不适用
ivWatch Sensor: Device Validation for Infiltrated Tissues
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ivWatch, LLC
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Red Notification Sensitivity to Infiltrated Tissues
研究概览
简要总结
A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Informed Consent
- •Pass health screen by clinician
- •18 years or older
排除标准
- •Fail health screen
结局指标
主要结局
Red Notification Sensitivity to Infiltrated Tissues
时间窗: After each participant has been infiltrated, an expected average of 1 hour
The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.
次要结局
- Yellow Notification Sensitivity to Infiltrated Tissues(After each participant has been infiltrated, an expected average of 1 hour)
- Infiltrated Volume When Red Notification Issued(After each participant has been infiltrated, an expected average of 1 hour)
- Infiltrated Volume When Yellow Notification Issued(After each participant has been infiltrated, an expected average of 1 hour)
- Significant Skin Irritation or Disruption to Skin Integrity(After each participant has been infiltrated, an expected average of 1 hour)
研究者
研究点 (2)
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