A cross sectional, non-randomized clinical performance study to collect the data using Vivaray Hb pro and use the device generated hemoglobin value for validation by comparing it with the hemoglobin value generated from the gold standard (calibrated blood cell counter).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 763
- 试验地点
- 4
- 主要终点
- The objective of the study is to validate the clinical performance of Vivaray Hb pro
研究概览
简要总结
The World Health Organization classifies anemia as decrease in the number red blood cells or insufficient oxygen carrying capacity to meet the physiological needs, which varies by age, sex, altitude, smoking and pregnancy status.
Deficiency in folate, vitamin-B12, vitamin-A, chronic inflammations, ulcers, pregnancy, parasitic infections, hemoglobinopathies, etc. can all lead to anemia, but iron-deficiency anemia is considered to be one of the leading causes of anemia in the world.
It is advisable for hemoglobin (Hb) values to be continuously measured among people who undergo hemodialysis or suspected with anemia and oligocythemia (Kavsaoglu, Polat, & Hariharan, 2015).
The purpose of this study tovalidate the clinical performance of Vivaray Hb pro and use the device generated hemoglobin value for validation by comparing it with the hemoglobin value generated from the gold standard (calibrated blood cell counter).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 9.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female patients with age of greater than eight (8) years
- •Range of Hemoglobin 4-18 g/dl.
- •Able to give written informed consent, assent or parents’ consent form.
- •Finger size: 8 mm to 23 mm (The device is designed to fit fingers in this range) and index finger preferred to capture the signal.
排除标准
- •Patients with paronychia, fungal infections of the nail bed, blistering disorders involving the fingers, hyper-keratosis, nail polish, mehendi and callus formation on nail.
结局指标
主要结局
The objective of the study is to validate the clinical performance of Vivaray Hb pro
时间窗: Enrolment and Study Completion Visit – Visit 1
and use the device generated hemoglobin value for validation by comparing it with the hemoglobin value generated from the gold standard (calibrated blood cell counter).
时间窗: Enrolment and Study Completion Visit – Visit 1
次要结局
- NA(NA)
研究者
Dr Dipti Gupta
Dr. Diptis Multispecialty Clinics