Non-Invasive Blood Test Cross-Validation Study

NCT ID: NCT03991637

Last Updated: 2019-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-18

Study Completion Date

2019-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Reproducibility of Results Safety Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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NICMP Spectral Reading

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

Group Type EXPERIMENTAL

Non-Invasive Comprehensive Metabolic Panel

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Non-Invasive Comprehensive Metabolic Panel

Intervention Type DEVICE

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

Interventions

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Non-Invasive Comprehensive Metabolic Panel

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Undiagnosed population

Exclusion Criteria

* Diagnosed population, pregnant women, mental heath/disabled, prisoners, fetus or deceased
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Dakota

OTHER

Sponsor Role collaborator

Joseph Allen Jr.

INDUSTRY

Sponsor Role lead

Responsible Party

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Joseph Allen Jr.

Chief Executive Officer/Biomedical Engineer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Altru Health System

Grand Forks, North Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-201807-004

Identifier Type: -

Identifier Source: org_study_id

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