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TerminatedNCT02104154Updated Feb 20, 2015

Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a Point-of-Care Setting

An observational study in Hepatic Disease, sponsored by Samsung Electronics. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2015-02-20.

Sponsored by Samsung Electronics · Observational

Why this study was terminated
To conduct interim analysis and assess whether assay changes are recommended.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
32
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hepatic Disease

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03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.

This study's enrollment of 32 is below the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Samsung Electronics is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Primary care clinics

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
32 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • symptoms of liver disease

    Device: Samsung LABGEO PT10 Hepatic Panel

    Device: Samsung LABGEO PT10 Hepatic Panel

Interventions

  • DeviceSamsung LABGEO PT10 Hepatic Panel
06

What researchers measure

Primary outcomes

  1. Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay

    Time frame: baseline

Secondary outcomes

  1. Mean percentage difference between all pairs of plasma and serum measurements using Bland-Altman plot of differences.

    Time frame: baseline

  2. Standard deviation and coefficients of variation of between run, between day and total precision.

    Time frame: 20 days

  3. 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

  4. Mean percentage difference between all pairs of serum and whole blood measurements using Bland-Altman plot of differences.

    Time frame: baseline

  5. Mean percentage difference between all pairs of plasma and whole blood measurements using Bland-Altman plot of differences.

    Time frame: baseline

07

Study locations

1 site
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02104154
Lead sponsor
Samsung Electronics
Responsible party
Sponsor
First posted
Apr 4, 2014
Start date
Nov 2013
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Feb 20, 2015

Study contacts

Nam Shin
study chair · Nexus DX

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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