Validation of Point of Care Liver Function Tests
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03800069|
Recruitment Status : Terminated (scheduling complexities)
First Posted : January 10, 2019
Last Update Posted : December 4, 2020
|Condition or disease||Intervention/treatment|
|Liver Diseases Healthy Cirrhosis, Liver Fibrosis||Device: Group K Diagnostic point of care device|
Outpatient diagnostics are slow and expensive due to turnaround times, complex workflows and high cost. Sometimes patients do not make it to laboratory testing if a lab is not available on site. Delays in testing can affect medical outcomes or patients can be lost to follow up.
Group K developed a paper microfluidic platform with an accompanying mobile application(app). The paper microfluidic device is a simple, inexpensive wax backed device with three testing areas. These areas have a mix of dried proprietary reagents that when combined with a patients drop of blood, or in the future, saliva or urine, will produce results in a color change. An app is then used to interpret the color change and output results to a doctor. The target population is adults who have an indication to collect a liver function panel that will be drawn on the same day as their clinic visit or during their inpatient hospital
|Study Type :||Observational|
|Actual Enrollment :||68 participants|
|Official Title:||Biomedical Device Trial of Validation of Point of Care Liver Function Tests|
|Actual Study Start Date :||December 3, 2018|
|Actual Primary Completion Date :||May 30, 2019|
|Actual Study Completion Date :||May 30, 2019|
A finger stick sample is collected and tested on the study device.
Device: Group K Diagnostic point of care device
Arm 1 will have a finger prick sample collected to test the ability of Group K Diagnostic point of care device and app to identify liver function values.
- Regression curve and correlation coefficient [ Time Frame: 1 year ]Each data point will represent one observation or one test run. The investigators will use regression methods to determine the linear relationship between standard lab results and Group K diagnostic's device.
- The consistent accuracy of the diagnostic device [ Time Frame: 1 year ]Lowest level frequency of detection must be detected 90% of the time. This will become the functional lower limit. The same with the highest level of frequency.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800069
|United States, Pennsylvania|
|The Hospital of the University of Pennslyvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Vandana Khungar, MD, MSc||Director of Inpatient Hepatology|