NCT03991637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

June 1, 2019

Last Update Submit

June 20, 2019

Conditions

Reproducibility of ResultsSafety Issues

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Non-Invasive Comprehensive Metabolic PanelDEVICE

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

NICMP Spectral ReadingVenipuncture CMP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undiagnosed population

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altru Health System

Grand Forks, North Dakota, 58201, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Executive Officer/Biomedical Engineer

Study Record Dates

First Submitted

June 1, 2019

First Posted

June 19, 2019

Study Start

July 18, 2018

Primary Completion

September 11, 2018

Study Completion

March 1, 2019

Last Updated

June 24, 2019

Record last verified: 2019-06

Locations

US(1)