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Non-Invasive Hemoglobin Study

Sponsor
Convergence Biometrics (Industry)
Overall Status
Completed
CT.gov ID
NCT02206399
Collaborator
DRMiller Engineering (Other)
237
Enrollment
1
Location
3
Duration (Months)
78.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    237 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Non-Invasive Hemoglobin Multi-Center Observational Study
    Study Start Date :
    Aug 1, 2014
    Actual Primary Completion Date :
    Nov 1, 2014
    Actual Study Completion Date :
    Nov 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Hemoglobin in Blood At Time of Test [Up to 30 seconds]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BloodSource Sacramento California United States 95655-4128

    Sponsors and Collaborators

    • Convergence Biometrics
    • DRMiller Engineering

    Investigators

    • Principal Investigator: Anne Igbokwe, MD, BloodSource
    • Principal Investigator: Chris Gresens, MD, BloodSource

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Convergence Biometrics
    ClinicalTrials.gov Identifier:
    NCT02206399
    Other Study ID Numbers:
    • BLS-1
    First Posted:
    Aug 1, 2014
    Last Update Posted:
    Jun 27, 2016
    Last Verified:
    Jun 1, 2016

    Study Results

    No Results Posted as of Jun 27, 2016