Status:

COMPLETED

Non-Invasive Hemoglobin Study

Lead Sponsor:

Convergence Biometrics

Collaborating Sponsors:

DRMiller Engineering

Conditions:

Anemia

Eligibility:

All Genders

18+ years

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...

Eligibility Criteria

Inclusion

  • Inclusion criteria for this study are:
  • Subject is capable of giving informed consent.
  • 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:
  • Age less than 18 years at time of research
  • Subject lacks the digits to place in the POCT device
  • Subject displays symptoms or has a history of Raynaud's disease
  • Subject has a neurological disorder resulting in an inability to hold the index finger steady for 20 sec.
  • Subject has a history of long term continuous decreased perfusion to either hand (\>30 days).
  • Subject has had surgery within the last 2 weeks on finger or hand that he wishes to use in the study
  • Subject's same day participation in this study
  • Capillary sample volume is not adequate to complete testing on the comparative device.
  • Cold agglutinin disease

Exclusion

    Key Trial Info

    Start Date :

    August 1 2014

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2014

    Estimated Enrollment :

    237 Patients enrolled

    Trial Details

    Trial ID

    NCT02206399

    Start Date

    August 1 2014

    End Date

    November 1 2014

    Last Update

    June 27 2016

    Active Locations (1)

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    BloodSource

    Sacramento, California, United States, 95655-4128