HematologyNCT03595501
Analytical and Clinical Performance Testing Plan
An observational study of Hematology and Hematologic Test, run by Sight Diagnostics at 1 site in United States.
Trial summary
Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications. Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Hematology, Hematologic Test
- What is being tested?
- Hematology Analyzer - OLO and Hematology Analyzer - Predicate
- Type of treatment
- Medical device
- How many people
- 679 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2018to 25 Aug 2019
- 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 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult and pediatric patients with normal (healthy) or abnormal blood counts (known clinical condition)
Who may be able to join
- For Residual Samples:
- Specimen obtained by venipuncture or finger prick and collected into tubes normally used by the site
- Patient is at least 3 months of age
- Samples within 8 hours from phlebotomy
- For Prospectively collected samples:
- Subject is at least 22 years of age
- Non-diseased individuals or, for specific studies, individuals with blood count ranges to cover indicated medical decision points and ranges
- Samples within 8 hours from phlebotomy
Who cannot join
- Exclusion criteria post blood draw and pre sample scan - For whole blood samples:
- Visibly hemolyzed or clotted specimens
- Specimens with insufficient blood volume to complete the procedure
- Samples older than eight hours
- Instrument failure or sample rejected by the instrument due to system error or sample mishandling
- The daily quality control sample measurements indicate that the assay run is outside the specifications for the instrument
- Operator related error documented in the study records
- Failure to adhere to study specifics or protocols
Trial locations and contacts
1 site in 1 country.
About this study
Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications.
Read the detailed description
Comparison and precision studies will be conducted in up to 5 clinical sites in Israel and the US, and include:
- Precision
- Sample Matrix Comparison
- Method comparison study and flagging analysis
- Reference interval range
- Conditions
- Hematology, Hematologic Test
- Being tested
- Hematology Analyzer - OLO, Hematology Analyzer - Predicate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematology Analyzer - OLODevice
Complete blood counts from OLO will be determined from analysis of whole blood samples
Hematology Analyzer - PredicateDevice
Complete blood counts from Predicate will be determined from analysis of whole blood samples
| Study group | Role | What they receive |
|---|---|---|
| Hematology Analyzer - OLO | The investigational device is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening capillary or venous whole blood samples. Receives: Device: Hematology Analyzer - OLO | |
| Hematology Analyzer - Predicate | The predicate device is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical and reference laboratories. Receives: Device: Hematology Analyzer - Predicate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of CBC parameters provided by the OLO device
Reproducibility studies will be conducted using 3 levels of commercial control materials (low, normal and high) to measure all CBC reported parameters. Control material will be run on two instruments at each site. Standard deviation (SD) and coefficient of variation (CV) will be calculated for each measurand for: (1) Between lots/sites; (2) Between instruments; (3) Between days; (4)Between operators/runs; (5) within-run and (6) total variability
Measured: 3 months
Repeatability of CBC parameters provided by the OLO device
Performance of the OLO device will be measured through repeatability of 20 replicates for 11 residual samples on each site. Samples collected for this study will include 4 within lab reference range, 3 around lower medical decision levels for HGB, PLT and WBC, and 4 around the upper range for RBC, HGB, WBC and PLT to cover all pathological levels and medical decision points. Standard deviation (SD) and coefficient of variation (CV) will be computed for each measurand per sample by site.
Measured: 3 months
Sample Matrix Comparison
Paird capillary and venous whole blood samples will be collected. The samples will be analyzed in duplicate on the Sight OLO device. Analysis will include Passing-Bablok Regression analysis per parameter (Bland Altman plots, slope, intercept, with 95% confidence intervals, correlation coefficient, and % bias), between: The average of venous whole blood samples scans and average of capillary whole blood sample scans from the same individual on the Sight OLO device
Measured: 3 months
Method Comparison
Evaluate the performance of the OLO device in comparison to values achieved with the predicate. Analysis will include Regression parameters (slope, intercept with 95% CI) between measurement of Sight OLO and measurement on predicate (Correlation coefficient, Bland Altman plots and overall % bias between predicate and Sight OLO device including % bias at medical decision points).
Measured: 3 months
Reference Interval Range
Establish adult venous and fingerprick reference intervals for the OLO device. The non-parametric method will be used to calculate the lower and upper limits of the reference range.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start20 Jun 2018
- Primary completion6 Mar 2019
- Study completion25 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematologyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 679 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sight Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Eldad Hod, Dr, Principal investigator, Colombia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595501
- Sponsor's protocol ID
- PR00014
- Status last verified
- Mar 2021
- First submitted
- 28 May 2018
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytical and Clinical Performance Testing Plan
- ClinicalTrials.gov ID
- NCT03595501
- Acronym / sponsor ID
- PR00014
- Conditions
- Hematology, Hematologic Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 679 participants (actual)
- Lead sponsor
- Sight DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 25 Aug 2019 (actual)
- First posted
- 23 Jul 2018 (actual)
- 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.
Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications.
Detailed description
Comparison and precision studies will be conducted in up to 5 clinical sites in Israel and the US, and include:
- Precision
- Sample Matrix Comparison
- Method comparison study and flagging analysis
- Reference interval range
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hematology Analyzer - OLO | – | Device: Hematology Analyzer - OLOThe investigational device is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening capillary or venous whole blood samples. |
| Hematology Analyzer - Predicate | – | Device: Hematology Analyzer - PredicateThe predicate device is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical and reference laboratories. |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric patients with normal (healthy) or abnormal blood counts (known clinical condition)
Key inclusion criteria (8 listed)
- Specimen obtained by venipuncture or finger prick and collected into tubes normally used by the site
- Patient is at least 3 months of age
- Samples within 8 hours from phlebotomy
- Subject is at least 22 years of age
- Non-diseased individuals or, for specific studies, individuals with blood count ranges to cover indicated medical decision points and ranges
Key exclusion criteria (8 listed)
- Visibly hemolyzed or clotted specimens
- Specimens with insufficient blood volume to complete the procedure
- Samples older than eight hours
- Instrument failure or sample rejected by the instrument due to system error or sample mishandling
- The daily quality control sample measurements indicate that the assay run is outside the specifications for the instrument
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hematology Analyzer - OLOComplete blood counts from OLO will be determined from analysis of whole blood samples | Device | Hematology Analyzer - OLO |
| Hematology Analyzer - PredicateComplete blood counts from Predicate will be determined from analysis of whole blood samples | Device | Hematology Analyzer - Predicate |
Primary outcome
Reproducibility of CBC parameters provided by the OLO device
Time frame: 3 months
Reproducibility studies will be conducted using 3 levels of commercial control materials (low, normal and high) to measure all CBC reported parameters. Control material will be run on two instruments at each site. Standard deviation (SD) and coefficient of variation (CV) will be calculated for each measurand for: (1) Between lots/sites; (2) Between instruments; (3) Between days; (4)Between operators/runs; (5) within-run and (6) total variability
Repeatability of CBC parameters provided by the OLO device
Time frame: 3 months
Performance of the OLO device will be measured through repeatability of 20 replicates for 11 residual samples on each site. Samples collected for this study will include 4 within lab reference range, 3 around lower medical decision levels for HGB, PLT and WBC, and 4 around the upper range for RBC, HGB, WBC and PLT to cover all pathological levels and medical decision points. Standard deviation (SD) and coefficient of variation (CV) will be computed for each measurand per sample by site.
Sample Matrix Comparison
Time frame: 3 months
Paird capillary and venous whole blood samples will be collected. The samples will be analyzed in duplicate on the Sight OLO device. Analysis will include Passing-Bablok Regression analysis per parameter (Bland Altman plots, slope, intercept, with 95% confidence intervals, correlation coefficient, and % bias), between: The average of venous whole blood samples scans and average of capillary whole blood sample scans from the same individual on the Sight OLO device
Method Comparison
Time frame: 3 months
Evaluate the performance of the OLO device in comparison to values achieved with the predicate. Analysis will include Regression parameters (slope, intercept with 95% CI) between measurement of Sight OLO and measurement on predicate (Correlation coefficient, Bland Altman plots and overall % bias between predicate and Sight OLO device including % bias at medical decision points).
Reference Interval Range
Time frame: 3 months
Establish adult venous and fingerprick reference intervals for the OLO device. The non-parametric method will be used to calculate the lower and upper limits of the reference range.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
Related trials for Hematology
Recruiting
HEME Home Transfusion Program
Leukemia, Myeloma
Active, not recruitingObservational study
Observatory of Prolymphocytic Leukemia T
Prolymphocytic Leukemia, T-cell Leukemia
RecruitingPhase 2
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingPhase 2
Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
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.
Dr. Eldad Hod, Dr principal investigator
Colombia University
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 Hematology and Hematologic Test, run by Sight Diagnostics at 1 site in United States.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 4 Mar 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of CBC parameters provided by the OLO device (time frame: 3 months). The study lists 5 primary outcomes in all. 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 4 Mar 2021.