NCT04305938

A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Kaligia Biosciences, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The purpose of the Kaligia Biosciences KBS Systems 1.0(b) analyte monitoring device is to measure the blood analyte levels in patients. The KBS Systems 1.0(b) device avoids the common practice of accessing the vein to draw blood for conventional laboratory analysis. Instead, the KBS Systems 1.0(b) device uses Raman Spectroscopy to acheive the measurement of various blood analytes through the use of only approximately 40µl of blood. Such a small volume of blood can be sampled via a finger prick procedure rather than needing a larger volume of blood sampled via a venipuncture. The spectra contain information of all the molecules present in the blood (RBCs, hemoglobin, glucose, sodium, potassium, etc.). From these spectra, the system is able to analyze the blood and provide results in a matter of minutes, rather than hours or even, in some cases, days.

Conditions

• Calibration and Validation of Analyte Testing System

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Minimally invasive and non-invasive blood analyte measurement	Rapid point-of-care minimally invasive blood analyzer consisting of a spectrometer and a computer loaded with Kaligia software that controls the data acquisition and signal processing to interpret blood analyte measurement.

Timeline

• Start date: 2020-04-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-03-12
• Last updated: 2020-03-12

Locations

1 site across 1 country: United States