Status:
UNKNOWN
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1
Lead Sponsor:
Kaligia Biosciences, LLC
Conditions:
Calibration and Validation of Analyte Testing System
Eligibility:
All Genders
18+ years
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 acce...
Eligibility Criteria
Inclusion
- Adults \> 18 yrs of age.
- Willingness and ability to provide informed consent
- Hospital patients with a physician-prescribed laboratory blood test
Exclusion
- People with clotting factor disorders and/or currently taking anticoagulation medication.
- 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).
- 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.
- 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.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04305938
Start Date
April 1 2020
End Date
December 31 2020
Last Update
March 12 2020
Active Locations (1)
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1
Tampa General Hospital
Tampa, Florida, United States, 33606