The hemoglobin data collection study by using Vivaray hb pro device developed by Bosch.
Not Applicable
- Conditions
- Health Condition 1: R799- Abnormal finding of blood chemistry, unspecifiedHealth Condition 2: R799- Abnormal finding of blood chemistry, unspecified
- Registration Number
- CTRI/2024/07/071199
- Lead Sponsor
- Bosch Global Software Technologies Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Male or Female patients with age of greater than eight (8) years
2. Range of Hemoglobin 4-18 g/dl.
3. Able to give written informed consent, assent or parents’ consent form.
4. 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.
Exclusion Criteria
1. Patients with paronychia, fungal infections of the nail bed, blistering disorders involving the fingers, hyper-keratosis, nail polish, mehendi and callus formation on nail.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The objective of the study is to validate the clinical performance of Vivaray Hb pro <br/ ><br> 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). <br/ ><br>Timepoint: Enrolment and Study Completion Visit – Visit 1 <br/ ><br>
- Secondary Outcome Measures
Name Time Method ATimepoint: NA