Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a... | NCT02104154

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

NCT02104154

Sponsor

Samsung Electronics

Status

Terminated

Last Update Posted

Feb 20, 2015Estimated

Enrollment

32Actual

Phase

Not provided

Conditions

Hepatic Disease

Interventions

Samsung LABGEO PT10 Hepatic Panel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

To conduct interim analysis and assess whether assay changes are recommended.

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Dec 13, 2013

First Submission Date that Met QC Criteria

Apr 1, 2014

First Posted Date

Apr 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2015

Last Update Posted Date

Feb 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
symptoms of liver disease		Device: Samsung LABGEO PT10 Hepatic Panel	Device: Samsung LABGEO PT10 Hepatic Panel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Samsung LABGEO PT10 Hepatic Panel	Device		symptoms of liver disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay		baseline

Secondary Outcomes

Measure	Description	Time Frame
Mean percentage difference between all pairs of plasma and serum measurements using Bland-Altman plot of differences.		baseline
Standard deviation and coefficients of variation of between run, between day and total precision.		20 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Primary care clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nam Shin	Nexus DX	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health & Science University		Portland	Oregon	97239	United States

Condition Browse Module

MeSH Terms

ID	Term
D004066	Digestive System Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided