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Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
Sponsor: Leuko Labs, Inc.
Summary
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.
Official title: Pivotal Study to Validate the Usability, Safety and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia
Key Details
Gender
All
Age Range
10 Years - Any
Study Type
OBSERVATIONAL
Enrollment
210
Start Date
2025-12-15
Completion Date
2027-06-30
Last Updated
2026-07-31
Healthy Volunteers
Not specified
Interventions
PointCheck
Binary classification of severe neutropenia
Locations (6)
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
MDA
Houston, Texas, United States
Hospital Universitario 12 de Octubre
Madrid, Spain