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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Primary Purpose: Supportive Care
- Masking: None (Open Label)
- Study Primary Completion Date: September 11, 2018
- 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
- 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
- Undiagnosed population
- 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
- Lead Sponsor
- Joseph Allen Jr.
- 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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