Non-Invasive Blood Test Cross-Validation Study

Joseph Allen Jr.

Status: Completed

Conditions: Safety Issues; Reproducibility of Results

Treatments: Device: Non-Invasive Comprehensive Metabolic Panel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03991637

IRB-201807-004

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Undiagnosed population

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

NICMP Spectral Reading

Experimental group

Description:

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

Treatment:

Device: Non-Invasive Comprehensive Metabolic Panel

Venipuncture CMP

Active Comparator group

Description:

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.

Treatment:

Device: Non-Invasive Comprehensive Metabolic Panel