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OpenTrials
Completed

NCT Number: NCT02206399

Non-Invasive Hemoglobin Study

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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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BloodSource

Sacramento, California, 95655-4128, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Hemoglobin in Blood At Time of Test

    Time frame: Up to 30 seconds

Sponsors and collaborators

Lead sponsor

Convergence Biometrics

Industry

Collaborators

  • DRMiller Engineering

Registry information

Official study title

Non-Invasive Hemoglobin Multi-Center Observational Study

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 1, 2014
Registry last updated
Jun 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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