NCT07009405招募中不适用
Continuous Monitoring of Intravenous Site Events With a Wireless Thermal Measurement Device During Outpatient Infusion Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Rhaeos, Inc.
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Thermal skin measurements
研究概览
简要总结
This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- 否
入选标准
- •Scheduled to receive an infusion therapy of at least 30 minutes in length
- •Region of intact skin proximal to the infusion catheter insertion site that is appropriate in size for application of the study device
- •Signed informed consent
- •Available for 15 minutes of post-measurement monitoring following removal of the study device
排除标准
- •Patient is under 12 years of age
- •Patient-reported history of serious adverse skin reactions to silicone-based adhesives or Tegaderm
- •Use of the study device would interfere with standard patient care that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
- •Investigator judges that the intravenous
结局指标
主要结局
Thermal skin measurements
时间窗: Up to 12 hours of monitoring with a 15-minute follow-up period.
Exploratory assessment of thermal skin measurements taken with the study device
次要结局
未报告次要终点
研究者
研究点 (2)
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