Non-Invasive Blood Test Cross-Validation Study

Sponsor

Joseph Allen Jr. (Industry)

Overall Status

Completed

CT.gov ID

NCT03991637

Collaborator

University of North Dakota (Other)

Enrollment

Location

Arms

7.4

Actual Duration (Months)

12.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Reproducibility of Results Safety Issues	Device: Non-Invasive Comprehensive Metabolic Panel	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Remote Sensing Comprehensive Metabolic Panel

Actual Study Start Date :

Jul 18, 2018

Actual Primary Completion Date :

Sep 11, 2018

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NICMP Spectral Reading Non-invasive spectral data is collected from this arm to function as the intervention of interest.	Device: Non-Invasive Comprehensive Metabolic Panel The device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations.
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.	Device: Non-Invasive Comprehensive Metabolic Panel The device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations.

Arm

Intervention/Treatment

Experimental: NICMP Spectral Reading

Non-invasive spectral data is collected from this arm to function as the intervention of interest.

Device: Non-Invasive Comprehensive Metabolic Panel

The device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations.

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.

Device: Non-Invasive Comprehensive Metabolic Panel

The device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Undiagnosed population

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altru Health System	Grand Forks	North Dakota	United States	58201

Sponsors and Collaborators

Joseph Allen Jr.
University of North Dakota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joseph Allen Jr., Chief Executive Officer/Biomedical Engineer, Concord Medical Technology Corporation

ClinicalTrials.gov Identifier:

NCT03991637

Other Study ID Numbers:

IRB-201807-004

First Posted:

Jun 19, 2019

Last Update Posted:

Jun 24, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Study Results

No Results Posted as of Jun 24, 2019