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NCT04305938

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

Status unknown Last updated 12 March 2020
What this trial tests

trial testing Minimally invasive and non-invasive blood analyte measurement in Calibration and Validation of Analyte Testing System in 1,000 participants. Status unknown.

Timeline
1 April 2020
Primary endpoint
31 December 2020
31 December 2020

Quick facts

Lead sponsorKaligia Biosciences, LLC
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment1,000
Start date1 April 2020
Primary completion31 December 2020
Estimated completion31 December 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Kaligia Biosciences, LLC

Who can join

18 and older, any sex, with Calibration and Validation of Analyte Testing System. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04305938.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing