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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
Group K Diagnostics Inc.
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
This study is testing the accuracy of a point of care device that tests liver function within 20 minutes. The target population will be any adult who had liver function tests ordered and to be drawn on the same day as enrollment.

Condition or disease Intervention/treatment
Liver Diseases Healthy Cirrhosis, Liver Fibrosis Device: Group K Diagnostic point of care device

Detailed Description:

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

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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Arm 1
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population will be selected from inpatient and clinic setting at The Hospital of the University of Pennsylvania.

Inclusion Criteria:

  • Have a liver function testing for the required 6 tests completed (Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), albumin, bilirubin, and total protein)
  • 18 years or older

Exclusion Criteria:

  • Inadequate blood sample obtained from finger stick
  • Inconclusive liver function testing
  • Not all 6 liver tests completed on the same sample
  • Liver tests not drawn for normal method at same time as finger stick.

Information from the National Library of Medicine

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

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United States, Pennsylvania
The Hospital of the University of Pennslyvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Group K Diagnostics Inc.
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Principal Investigator: Vandana Khungar, MD, MSc Director of Inpatient Hepatology
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Study Protocol  [PDF] November 28, 2018
Informed Consent Form  [PDF] November 28, 2018

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03800069    
Other Study ID Numbers: 829476
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Liver Cirrhosis
Pathologic Processes
Digestive System Diseases