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

• Conditions: Calibration and Validation of Analyte Testing System

• Registration Number: NCT04305938
• Lead Sponsor: Kaligia Biosciences, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Study First Posted: 2020-03-12
• Last Update Posted: 2020-03-12
• Study Start: 2020-04-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Adults > 18 yrs of age.
• Willingness and ability to provide informed consent
• Hospital patients with a physician-prescribed laboratory blood test

Exclusion Criteria

1. People with clotting factor disorders and/or currently taking anticoagulation medication.
2. Has any other medical condition that, in the opinion of the Investigator, would interfere with the person's participation in this study (i.e. double arm amputee).
3. Any skin abnormalities or tattoos located on the palm(s) of the hand(s). The left palm is preferred for this study; however, the right palm can be used if the left palm is excluded.
4. Parkinson's disease, dyskinesia, tremors, or similar that may make it challenging for said person to hold their hand on the device in a still and stable manner.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analyte validation	6 months	CLIA laboratory analyte values will be compared to device analyte readings and inform machine learning of device software learning to achieve device calibration and validation of readings.

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States