HematologyNCT04618848
Performance Evaluation Study
An observational study of Hematology, run by Sight Diagnostics.
Trial summary
This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematology
- What is being tested?
- Fingerstick blood draw
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oncologic patient
Who may be able to join
- Blood samples will be collected from oncologic patients older than 18 years old arriving at the oncologic daily care center of Ichilov hospital, with predefined normal and abnormal blood counts
Who cannot join
- Patient younger than 18 years old
- Visibly hemolyzed specimens (sample plasma should be checked for hemolysis by technician while selection of specimen from tube racks).
- Visibly clotted specimens (Reasonable to assume that samples processed with clinical reported results are not clotted).
- A sample that is not successfully scanned on OLO within 3 attempts (e.g. rejected due to irregular cell morphology, or microscopically visible hemolysis).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Performance Evaluation Protocol for Sight Diagnostics' OLO CBC Analyzer by Ichilov Oncology Daily Care Center
This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points
Read the detailed description
This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points.
The evaluation will include two studies:
- A matrix study will compare a capillary sample collected via finger prick with a venous sample collected into a blood tube, both scanned on OLO.
- A method comparison study will compare Sight OLO to the site reference analyzer using a venous sample collected into a blood tube.
- Conditions
- Hematology
- Being tested
- Fingerstick blood draw
- Keywords
- Hematology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingerstick blood drawDiagnostic test
Each participant shall be pricked twice in order to perform CBC test
| Study group | Role | What they receive |
|---|---|---|
| Adult Oncology Patients | Adult oncology patients Receives: Diagnostic Test: Fingerstick blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBC Comparison
Comparison between CBC results obtained from the Sight OLO and the reference device in venous and capillary samples covering medical decision points relevant to onclology patient
Measured: Immediately after sample collection is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sight Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tel Aviv Medical Center
- Responsible party
- Sponsor
- Investigators
- Yochay Eshel, Principal investigator, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618848
- Sponsor's protocol ID
- PR0156
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation Protocol for Sight Diagnostics' OLO CBC Analyzer by Ichilov Oncology Daily Care Center
- ClinicalTrials.gov ID
- NCT04618848
- Acronym / sponsor ID
- PR0156
- Conditions
- Hematology
- Keywords
- Hematology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sight DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Tel Aviv Medical Center
- Study start
- Nov 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Nov 2020 (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.
This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points
Detailed description
This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points.
The evaluation will include two studies:
- A matrix study will compare a capillary sample collected via finger prick with a venous sample collected into a blood tube, both scanned on OLO.
- A method comparison study will compare Sight OLO to the site reference analyzer using a venous sample collected into a blood tube.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Oncology Patients | – | Diagnostic Test: Fingerstick blood drawAdult oncology patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncologic patient
Key inclusion criteria (1 listed)
- Blood samples will be collected from oncologic patients older than 18 years old arriving at the oncologic daily care center of Ichilov hospital, with predefined normal and abnormal blood counts
Key exclusion criteria (4 listed)
- Patient younger than 18 years old
- Visibly hemolyzed specimens (sample plasma should be checked for hemolysis by technician while selection of specimen from tube racks).
- Visibly clotted specimens (Reasonable to assume that samples processed with clinical reported results are not clotted).
- A sample that is not successfully scanned on OLO within 3 attempts (e.g. rejected due to irregular cell morphology, or microscopically visible hemolysis).
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 |
|---|---|---|
| Fingerstick blood drawEach participant shall be pricked twice in order to perform CBC test | Diagnostic test | Adult Oncology Patients |
Primary outcome
CBC Comparison
Time frame: Immediately after sample collection is completed
Comparison between CBC results obtained from the Sight OLO and the reference device in venous and capillary samples covering medical decision points relevant to onclology patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Yochay Eshel principal investigator
Sponsor GmbH
Questions about this trial
What is this clinical trial studying?
An observational study of Hematology, run by Sight Diagnostics.
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 4 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 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Yochay Eshel (+972-52-8505747, yochay@sightdx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBC Comparison (time frame: Immediately after sample collection is completed). 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 6 Nov 2020.