Liver DiseasesNCT03800069
Validation of Point of Care Liver Function Tests
An observational study of Liver Diseases and Healthy, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases, Healthy, Cirrhosis, Liver
- What is being tested?
- Group K Diagnostic point of care device
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2018to 30 May 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will be selected from inpatient and clinic setting at The Hospital of the University of Pennsylvania.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hospital of the University of Pennslyvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Biomedical Device Trial of Validation of Point of Care Liver Function Tests
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.
Read the 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
- Conditions
- Liver Diseases, Healthy, Cirrhosis, Liver, Fibrosis
- Being tested
- Group K Diagnostic point of care device
- Medical subject headings
- Liver Diseases, Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group K Diagnostic point of care deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | A finger stick sample is collected and tested on the study device. Receives: Device: Group K Diagnostic point of care device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression curve and correlation coefficient
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.
Measured: 1 year
Secondary outcomes (1)
The consistent accuracy of the diagnostic device
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start3 Dec 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Why it stopped: scheduling complexities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Group K Diagnostics Inc.
- Responsible party
- Sponsor
- Investigators
- Vandana Khungar, MD, MSc, Principal investigator, Director of Inpatient Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800069
- Sponsor's protocol ID
- 829476
- Status last verified
- Dec 2020
- First submitted
- 7 Jan 2019
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomedical Device Trial of Validation of Point of Care Liver Function Tests
- ClinicalTrials.gov ID
- NCT03800069
- Acronym / sponsor ID
- 829476
- Conditions
- Liver Diseases, Healthy, Cirrhosis, Liver, Fibrosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: scheduling complexities
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Group K Diagnostics Inc.
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 10 Jan 2019 (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.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Device: Group K Diagnostic point of care deviceA finger stick sample is collected and tested on the study device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be selected from inpatient and clinic setting at The Hospital of the University of Pennsylvania.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Group K Diagnostic point of care deviceArm 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. | Device | Arm 1 |
Primary outcome
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.
1 secondary outcome
The consistent accuracy of the diagnostic device
Time frame: 1 year
Results and safety
The study was stopped early (reason given: scheduling complexities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Vandana Khungar, MD, MSc principal investigator
Director of Inpatient Hepatology
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 Liver Diseases and Healthy, run by University of Pennsylvania 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 2 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: stopped early, as of the sponsor's last update on 4 Dec 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?
The study was stopped early (reason given: scheduling complexities). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression curve and correlation coefficient (time frame: 1 year). 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 4 Dec 2020.