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NCT04305938
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1
trial testing Minimally invasive and non-invasive blood analyte measurement in Calibration and Validation of Analyte Testing System in 1,000 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | Kaligia Biosciences, LLC |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 1 April 2020 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Minimally invasive and non-invasive blood analyte measurement
Conditions studied
- Calibration and Validation of Analyte Testing System — all drugs for Calibration and Validation of Analyte Testing System →
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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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04305938 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kaligia Biosciences, LLC
- Last refreshed: 12 March 2020
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