Calibration and Validation of Analyte Testing SystemNCT04305938
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1
An observational study of Calibration and Validation of Analyte Testing System, run by Kaligia Biosciences, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calibration and Validation of Analyte Testing System
- What is being tested?
- Minimally invasive and non-invasive blood analyte measurement
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adults > 18 yrs of age.
- Willingness and ability to provide informed consent
- Hospital patients with a physician-prescribed laboratory blood test
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tampa General Hospital
Tampa, Florida, 33606
Jennifer Olvedy, 813-660-6643, JOlvedy@tgh.org
TGH Office of Clinical Research, 813-844-2673, research@tgh.org
About this study
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.
- Being tested
- Minimally invasive and non-invasive blood analyte measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive and non-invasive blood analyte measurementDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calibration and Validation of Analyte Testing SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaligia Biosciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305938
- Sponsor's protocol ID
- KBS004
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1
- ClinicalTrials.gov ID
- NCT04305938
- Acronym / sponsor ID
- KBS004
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kaligia Biosciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Adults > 18 yrs of age.
- Willingness and ability to provide informed consent
- Hospital patients with a physician-prescribed laboratory blood test
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive and non-invasive blood analyte measurementRapid 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. | Diagnostic test | – |
Primary outcome
Analyte validation
Time frame: 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Calibration and Validation of Analyte Testing System, run by Kaligia Biosciences, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janice Shirley, MPH (813-919-8857, advancedclinicalresearch@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyte validation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.