New York, New York 10032


Purpose:

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.


Study summary:

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


Criteria:

Inclusion Criteria: 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 Exclusion Criteria: 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 Exclusion criteria post sample scan: - 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


NCT ID:

NCT03595501


Primary Contact:

Principal Investigator
Dr. Eldad Hod, Dr
Colombia University

Sarah Levy Schreier, MA
Phone: +972542446468
Email: sarah@sightdx.com


Backup Contact:

Email: amalia@sightdx.com
amalia Schreier, MA
Phone: +972-545-892105


Location Contact:

New York, New York 10032
United States

Jane Netterwald
Email: jn355@cumc.columbia.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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