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

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ClinicalTrials.gov Identifier: NCT02104154
Recruitment Status : Terminated (To conduct interim analysis and assess whether assay changes are recommended.)
First Posted : April 4, 2014
Last Update Posted : February 20, 2015
Sponsor:
Information provided by (Responsible Party):
Samsung Electronics

Tracking Information
First Submitted Date December 13, 2013
First Posted Date April 4, 2014
Last Update Posted Date February 20, 2015
Study Start Date November 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2014)
Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay [ Time Frame: baseline ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02104154 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 1, 2014)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a Point-of-Care Setting
Official Title Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a Point-of-Care Setting
Brief 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Retaining serum and plasma specimens
Sampling Method Non-Probability Sample
Study Population Primary care clinics
Condition Hepatic Disease
Intervention Device: Samsung LABGEO PT10 Hepatic Panel
Study Groups/Cohorts symptoms of liver disease
Device: Samsung LABGEO PT10 Hepatic Panel
Intervention: Device: Samsung LABGEO PT10 Hepatic Panel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: February 18, 2015)
32
Original Estimated Enrollment
 (submitted: April 1, 2014)
440
Actual Study Completion Date September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02104154
Other Study ID Numbers T10-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Samsung Electronics
Study Sponsor Samsung Electronics
Collaborators Not Provided
Investigators
Study Chair: Nam Shin Nexus-Dx
PRS Account Samsung Electronics
Verification Date February 2015