Blood Routine ExaminationNCT02894762
Performance Evaluation of In-Vitro Diagnostic Device
An observational study of Blood Routine Examination, run by Lite-On Technology Corporation H.S.P.B at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Routine Examination
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2015to Dec 2017
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adults
Who may be able to join
- You must be an adult over 20 years of age and weigh over 50 kg to be eligible to participate in the study.
Who cannot join
- You may not participate in this study if you do not meet the above inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
YUE E Wu, 886-913-772-512, duck1038@gmail.com
HUNG-YUAN LI, MD
About this study
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
- Conditions
- Blood Routine Examination
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Routine ExaminationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lite-On Technology Corporation H.S.P.B
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894762
- Sponsor's protocol ID
- 201410068DSD
- Status last verified
- Sep 2016
- First submitted
- 16 Aug 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of In-Vitro Diagnostic Device
- ClinicalTrials.gov ID
- NCT02894762
- Acronym / sponsor ID
- 201410068DSD
- Conditions
- Blood Routine Examination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lite-On Technology Corporation H.S.P.BIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- First posted
- 9 Sep 2016 (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.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adults
Key inclusion criteria (1 listed)
- You must be an adult over 20 years of age and weigh over 50 kg to be eligible to participate in the study.
Key exclusion criteria (1 listed)
- You may not participate in this study if you do not meet the above inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Time frame: 6 months
Measured results will collected from the at least 120 individuals of adults for each biochemical indicator.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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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.
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 Blood Routine Examination, run by Lite-On Technology Corporation H.S.P.B at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Sep 2016. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Audrey Lin (886-3-5787722 ext. 5800, Audrey.lin@liteon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 6 months). 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 9 Sep 2016.