Healthy Clinical Trial
Official title:
Collection of Blood Products for Use in the Development and Validation of Point-of-Care In Vitro Diagnostic Liver Function Test Devices
NCT number | NCT05457543 |
Other study ID # | GKD001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 30, 2022 |
Est. completion date | March 2023 |
This is an observational study exploring the performance of a novel point-of-care diagnostic testing platform designed to quantitate the presence of liver function biomarkers such as bilirubin. Blood samples will be collected from participants to further development and validation of the testing platform to support FDA review. The diagnostic device is intended to provide rapid in-office test results using a finger stick of blood, a reaction test device, and a smartphone app.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | March 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age and older - Able to read and understand an informed consent form written in English Exclusion Criteria: - Pregnancy - Participated in the present study within the last 6 days - Subject is subjectively unwell at the time of enrollment visit - Subject previously participated and has asked to be withdrawn from the study |
Country | Name | City | State |
---|---|---|---|
United States | Group K Diagnostics | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Group K Diagnostics Inc. |
United States,
AuYoung B, Gutha Ravichandran A, Patel D, Dave N, Shah A, Wronko-Stevens B, Bettencourt F, Menon N. Low-cost paper-based device for the colorimetric quantification of bilirubin in serum using smartphone technology. Frontiers in Chemistry. 2022; 10: 869086.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Regression analysis of bilirubin test results | Regression and other statistical analyses will be applied to bilirubin tests results to evaluate quantitation linearity, precision, and accuracy relative to a predicate device. | 6 months | |
Secondary | Sensitivity of image analysis to changes in concentration of test analyte | Investigational device compositions will be evaluated for the resolution of colorimetric change as read by image analysis as the concentration of test analyte changes. | 9 months |
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