Clinical trial · Observational
Performance Evaluation Study
Performance Evaluation Protocol for Sight Diagnostics' OLO CBC Analyzer by Ichilov Oncology Daily Care Center
NCT04618848CI-TRIAL-00048167unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fingerstick blood draw | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adult Oncology Patients
- description
- Adult oncology patients
- interventionNames
- Diagnostic Test: Fingerstick blood draw
Primary outcomes (1)
- measure
- CBC Comparison
- timeFrame
- Immediately after sample collection is completed
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.