Anemia
Conditions
Brief summary
The investigators clinical trials will be for a medical device that is non-invasive in nature. The investigators will be studying whether their non-invasive medical device gets data that is as good as, or better than, an FDA previously approved, blood analysis device. There is no study hypothesis for this study.
Interventions
None listed
Sponsors
DRMiller Engineering
Convergence Biometrics
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for this study are: 1. Subject is capable of giving informed consent. 2. Subject has an anatomically intact digit capable of having a capillary sample taken and of being placed in the POCT device.
Exclusion criteria
for this study are: 1. Age less than 18 years at time of research 2. Subject lacks the digits to place in the POCT device 3. Subject displays symptoms or has a history of Raynaud's disease 4. Subject has a neurological disorder resulting in an inability to hold the index finger steady for 20 sec. 5. Subject has a history of long term continuous decreased perfusion to either hand (\>30 days). 6. Subject has had surgery within the last 2 weeks on finger or hand that he wishes to use in the study 7. Subject's same day participation in this study 8. Capillary sample volume is not adequate to complete testing on the comparative device. 9. Cold agglutinin disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Hemoglobin in Blood At Time of Test | Up to 30 seconds |
Countries
United States
Outcome results
None listed