Performance Evaluation of In-Vitro Diagnostic Device | NCT02894762

Studies
Performance Evaluation of In-Vitro Diagnostic Device

NCT02894762

Sponsor

Lite-On Technology Corporation H.S.P.B

Status

Unknown status

Last Update Posted

Sep 9, 2016Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Blood Routine Examination

Interventions

Not provided

Countries

Taiwan

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2017Estimated

Completion Date

Not provided

First Submitted Date

Aug 16, 2016

First Submission Date that Met QC Criteria

Sep 8, 2016

First Posted Date

Sep 9, 2016Estimated

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

Sep 8, 2016

Last Update Posted Date

Sep 9, 2016Estimated

Description Module

Brief Summary

This is an interim report for POC testing of skyla Clinical Chemistry Analyzer and four skyla Test Systems (ALB, BUN, GLU, and TP). The analyses are performed with skyla Clinical Chemistry Analyzer.

Analyte Principle:

Albumin (ALB) - Dye-Binding BCG

Blood urea nitrogen (BUN) - Urease with GLDH (coupled enzyme)

Glucose (GLU) - Hexokinase, Colorimetry

Total Protein (TP) - Biuret

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quantitative measurement of biochemical indicators in the blood of adult that include of Albumin (ALB), Blood urea nitrogen (BUN), Glucose (GLU), and Total Protein (TP).	Measured results will collected from the at least 120 individuals of adults for each biochemical indicator.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

You must be an adult over 20 years of age and weigh over 50 kg to be eligible to participate in the study.

Exclusion Criteria:

You may not participate in this study if you do not meet the above inclusion criteria.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adults

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Audrey Lin	Contact	886-3-5787722	5800	Audrey.lin@liteon.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan