Performance Evaluation Study

Hematology Clinical Trial

Official title:

Performance Evaluation Protocol for Sight Diagnostics' OLO CBC Analyzer by Ichilov Oncology Daily Care Center

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04618848
• Other study ID #: PR0156
• Status: Not yet recruiting
• Start date: November 2020
• Est. completion date: December 2020

Study information

• Verified date: November 2020
• Source: Sight Diagnostics
• Contact: Yochay Eshel
• Phone: +972-52-8505747
• Email: yochay[@]sightdx.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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: 1. 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. 2. A method comparison study will compare Sight OLO to the site reference analyzer using a venous sample collected into a blood tube.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Hematology

Intervention

Diagnostic Test:
• Fingerstick blood draw
Each participant shall be pricked twice in order to perform CBC test

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sight Diagnostics	Tel Aviv Medical Center

Outcome

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