Non-Invasive Blood Test Cross-Validation Study

Overview

The study considers a cross-validation approach to determine the effectiveness of a non-invasive comprehensive metabolic panel (NICMP), relative to the venipuncture method. The NICMP machine learned powered device utilizes a light sensor to capture readings from either palm. The study (n=90) proves an agreement and strong correlation with respect to the NICMP and venipuncture blood draw.

Full Title of Study: “Remote Sensing Comprehensive Metabolic Panel”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 11, 2018

Interventions

  • Device: Non-Invasive Comprehensive Metabolic Panel
    • The device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations.

Arms, Groups and Cohorts

  • Experimental: NICMP Spectral Reading
    • Non-invasive spectral data is collected from this arm to function as the intervention of interest.
  • Active Comparator: Venipuncture CMP
    • A standard CMP blood draw is performed to function as the “gold standard” reference value. Specifically, the outcome of the experimental arm is cross-validated against the active comparator arm to determine the NICMP accuracy, relative to the venipuncture method.

Clinical Trial Outcome Measures

Primary Measures

  • Performance of Non-Invasive Comprehensive Metabolic Panel
    • Time Frame: 2-minutes
    • Determine the effectiveness, in terms of accuracy, of the NICMP against the venipuncture CMP (i.e. reference value).

Participating in This Clinical Trial

Inclusion Criteria

  • Undiagnosed population

Exclusion Criteria

  • Diagnosed population, pregnant women, mental heath/disabled, prisoners, fetus or deceased

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Joseph Allen Jr.
  • Collaborator
    • University of North Dakota
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Joseph Allen Jr., Chief Executive Officer/Biomedical Engineer – Concord Medical Technology Corporation

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