Non-Invasive Blood Test Cross-Validation Study

Safety Issues Clinical Trial

Official title:

Remote Sensing Comprehensive Metabolic Panel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991637
• Other study ID #: IRB-201807-004
• Status: Completed
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: June 2019
• Source: Concord Medical Technology Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 1, 2019
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undiagnosed population

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Reproducibility of Results
• Safety Issues

Intervention

Device:
• Non-Invasive Comprehensive Metabolic Panel
The device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations.

Locations

Country	Name	City	State
United States	Altru Health System	Grand Forks	North Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Joseph Allen Jr.	University of North Dakota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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