Non-Invasive Blood Test Cross-Validation Study | NCT03991637 | Trialant

Non-Invasive Blood Test Cross-Validation Study | NCT03991637 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NICMP Spectral Reading	Experimental	Non-invasive spectral data is collected from this arm to function as the intervention of interest.	Device: Non-Invasive Comprehensive Metabolic Panel
Venipuncture CMP	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Invasive Comprehensive Metabolic Panel	Device	The device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations.	NICMP Spectral Reading

Outcomes Module

Primary Outcomes

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