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NCT06323447

Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia

Sponsor: Leuko Labs, Inc.

View on ClinicalTrials.gov

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

2025-04-01

Completion Date

2026-04-28

Last Updated

2024-10-09

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

PointCheck

Binary classification of severe neutropenia