Non-Invasive Hemoglobin Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

237 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes