A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2020
CompletedFirst Posted
Study publicly available on registry
March 12, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 12, 2020
March 1, 2020
9 months
March 9, 2020
March 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Analyte validation
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.
6 months
Interventions
Rapid point-of-care minimally invasive blood analyzer consisting of a spectrometer and a computer loaded with Kaligia software that controls the data acquisition and signal processing to interpret blood analyte measurement.
Eligibility Criteria
The research subjects subjected to the test articles used in this study will be hospital patients with doctor-prescribed blood tests as standard of care.
You may qualify if:
- Adults \> 18 yrs of age.
- Willingness and ability to provide informed consent
- Hospital patients with a physician-prescribed laboratory blood test
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tampa General Hospital
Tampa, Florida, 33606, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2020
First Posted
March 12, 2020
Study Start
April 1, 2020
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 12, 2020
Record last verified: 2020-03