Non-Invasive Blood Test Cross-Validation Study

Not Applicable

Completed

• Conditions: Reproducibility of Results; Safety Issues
• Interventions: Device: Non-Invasive Comprehensive Metabolic Panel

• Registration Number: NCT03991637
• Lead Sponsor: Joseph Allen Jr.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-18
• Primary Completion: 2018-09-11
• Study Completion: 2019-03-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-01
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Undiagnosed population

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Venipuncture CMP	Non-Invasive Comprehensive Metabolic Panel	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.
NICMP Spectral Reading	Non-Invasive Comprehensive Metabolic Panel	Non-invasive spectral data is collected from this arm to function as the intervention of interest.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Altru Health System; 🇺🇸 Grand Forks, North Dakota, United States