NCT04490863已完成不适用
Noninvasive Hemoglobin Spot Check Repeatability and Reproducibility in a Blood Donation Setting
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
- 26
- 试验地点
- 1
- 主要终点
- Coefficient of Variation of Rad-67
研究概览
简要总结
The primary objective of this clinical investigation is to report on the repeatability and reproducibility of SpHb measurements from Rad-67 devices and DCI Mini sensors used to screen prospective blood donors at a donation center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •At least 18 years of age
- •Weight at least 110 pounds
- •Subjects with the intention of being screened for eligibility to donate blood
- •The subject has given written informed consent to participate in the study
排除标准
- •Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc.
- •Subjects unwilling to remove nail polish or acrylic nails
- •Subjects with blood cancers such as leukemia
- •Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia or with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc.
- •Subjects with self-disclosed/known pregnancy at the time of enrollment
- •Subjects deemed not suitable for the study at the discretion of the investigator
- •Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
研究组 & 干预措施
Test subjects
Experimental
All subjects are enrolled and receive Rad-67 Pulse oximeter & DCI Mini sensor for measurement of hemoglobin.
干预措施: Rad-67 Pulse oximeter & DCI Mini sensor (Device)
结局指标
主要结局
Coefficient of Variation of Rad-67
时间窗: Approximately 90 minutes per subject
Coefficient of variation will be computed using Repeatability and Reproducibility variance.
次要结局
未报告次要终点
研究者
研究点 (1)
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