Hepatic DiseaseNCT02104154
Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a Point-of-Care Setting
An observational study of Hepatic Disease, run by Samsung Electronics at 1 site in United States.
Trial summary
To establish the performance characteristics of the Samsung LABGEO PT10 by comparing the test results of the PT10 Hepatic assay with results obtained from an FDA-cleared chemistry analyzer. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatic Disease
- What is being tested?
- Samsung LABGEO PT10 Hepatic Panel
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Sep 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Primary care clinics
Who may be able to join
- Male or female subjects with a history of elevated liver enzymes or symptoms suggestive of elevated liver enzymes
- Presenting to the site and requiring testing for levels of liver enzymes as part of routine care at the site
- Subjects able and willing to provide written informed consent
Who cannot join
- Subjects unable or unwilling to provide written informed consent
- Subjects with a life-threatening disease or any serious, potentially life-threatening medical illness that may compromise patient safety or study conduct
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
To establish the performance characteristics of the Samsung LABGEO PT10 by comparing the test results of the PT10 Hepatic assay with results obtained from an FDA-cleared chemistry analyzer.
Read the detailed description
To establish the correlation between measurand values as obtained from the Samsung LABGEO PT10 Hepatic Panel at the point of care, and the corresponding measurand values as obtained on a commercial clinical chemistry analyzer, with respect to prospectively collected human serum specimens.
- Conditions
- Hepatic Disease
- Being tested
- Samsung LABGEO PT10 Hepatic Panel
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samsung LABGEO PT10 Hepatic PanelDevice
| Study group | Role | What they receive |
|---|---|---|
| symptoms of liver disease | Device: Samsung LABGEO PT10 Hepatic Panel Receives: Device: Samsung LABGEO PT10 Hepatic Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay
Measured: baseline
Secondary outcomes (5)
Mean percentage difference between all pairs of plasma and serum measurements using Bland-Altman plot of differences.
Measured: baseline
Standard deviation and coefficients of variation of between run, between day and total precision.
Measured: 20 days
Estimates of reference intervals by computing the 2.5th percentile of associated distribution of test measurement (for each analyte) and the 97.5th percentile of associated distribution.
Measured: baseline
Mean percentage difference between all pairs of serum and whole blood measurements using Bland-Altman plot of differences.
Measured: baseline
Mean percentage difference between all pairs of plasma and whole blood measurements using Bland-Altman plot of differences.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: To conduct interim analysis and assess whether assay changes are recommended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Electronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nam Shin, Study chair, Nexus DX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104154
- Sponsor's protocol ID
- T10-02
- Status last verified
- Feb 2015
- First submitted
- 13 Dec 2013
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a Point-of-Care Setting
- ClinicalTrials.gov ID
- NCT02104154
- Acronym / sponsor ID
- T10-02
- Conditions
- Hepatic Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: To conduct interim analysis and assess whether assay changes are recommended.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Samsung ElectronicsIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Apr 2014 (estimated)
- 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.
To establish the performance characteristics of the Samsung LABGEO PT10 by comparing the test results of the PT10 Hepatic assay with results obtained from an FDA-cleared chemistry analyzer.
Detailed description
To establish the correlation between measurand values as obtained from the Samsung LABGEO PT10 Hepatic Panel at the point of care, and the corresponding measurand values as obtained on a commercial clinical chemistry analyzer, with respect to prospectively collected human serum specimens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptoms of liver disease | – | Device: Samsung LABGEO PT10 Hepatic PanelDevice: Samsung LABGEO PT10 Hepatic Panel |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinics
Key inclusion criteria (3 listed)
- Male or female subjects with a history of elevated liver enzymes or symptoms suggestive of elevated liver enzymes
- Presenting to the site and requiring testing for levels of liver enzymes as part of routine care at the site
- Subjects able and willing to provide written informed consent
Key exclusion criteria (2 listed)
- Subjects unable or unwilling to provide written informed consent
- Subjects with a life-threatening disease or any serious, potentially life-threatening medical illness that may compromise patient safety or study conduct
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 |
|---|---|---|
| Samsung LABGEO PT10 Hepatic Panel | Device | symptoms of liver disease |
Primary outcome
Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay
Time frame: baseline
5 secondary outcomes
Mean percentage difference between all pairs of plasma and serum measurements using Bland-Altman plot of differences.
Time frame: baseline
Standard deviation and coefficients of variation of between run, between day and total precision.
Time frame: 20 days
Estimates of reference intervals by computing the 2.5th percentile of associated distribution of test measurement (for each analyte) and the 97.5th percentile of associated distribution.
Time frame: baseline
Mean percentage difference between all pairs of serum and whole blood measurements using Bland-Altman plot of differences.
Time frame: baseline
Mean percentage difference between all pairs of plasma and whole blood measurements using Bland-Altman plot of differences.
Time frame: baseline
Results and safety
The study was stopped early (reason given: To conduct interim analysis and assess whether assay changes are recommended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
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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.
Nam Shin study chair
Nexus DX
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 Hepatic Disease, run by Samsung Electronics 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 2 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 20 Feb 2015. 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: To conduct interim analysis and assess whether assay changes are recommended.). 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?
Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay (time frame: baseline). 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 20 Feb 2015.