PointCheck
Diagnostic TestBinary classification of severe neutropenia
NCT Number: NCT06323447
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.
Trial opening soon.
Get Notified10 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Binary classification of severe neutropenia
Time frame: Two weeks
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
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
Mean System Usability Score
Time frame: Two-weeks
Device related errors (number/type)
Time frame: Two-weeks
total number (and %) of AEs and SAEs related to the device use.
Contact information is provided by the study sponsor or research team.
Leuko Labs, Inc.
Industry
Pivotal Study to Validate the Usability, Safety and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia
Acronym: PC002
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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