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

Kaligia Biosciences

Status: Unknown

Conditions: Calibration and Validation of Analyte Testing System

Treatments: Diagnostic Test: Minimally invasive and non-invasive blood analyte measurement

Study type: Observational

Funder types: Industry

Identifiers

NCT04305938

KBS004

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.