Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.
Study Type
OBSERVATIONAL
Enrollment
210
Binary classification of severe neutropenia
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Norton Healthcare Cancer Center
Louisville, Kentucky, United States
Massachussetts General Hospital
Boston, Massachusetts, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
PointCheck Accuracy
The main primary endpoints for this study will be the sensitivity and specificity of PointCheckTM to detect grade IV neutropenia ac cording to the CTCAE V5 definition of severe neutropenia in a standard blood analysis.
Time frame: Two weeks
PointCheck Precision
Repeatability and reproducibility will be assessed using the % positive/negative results of the test's classification compared to the gold standard after multiple measurements in different contexts.
Time frame: Two-weeks
PointCheck Usability
Mean System Usability Score
Time frame: Two-weeks
PointCheck Errors
Device related errors (number/type)
Time frame: Two-weeks
PointCheck Safety
total number (and %) of AEs and SAEs related to the device use.
Time frame: Two-weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MDA
Houston, Texas, United States
Hospital Universitario 12 de Octubre
Madrid, Spain