Hematology Clinical Trial
Official title:
Performance Evaluation Protocol for Sight Diagnostics' OLO CBC Analyzer by Ichilov Oncology Daily Care Center
NCT number | NCT04618848 |
Other study ID # | PR0156 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 2020 |
Est. completion date | December 2020 |
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
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sight Diagnostics | Tel Aviv Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Immediately after sample collection is completed |
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