Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
NCT06323447 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 210
Last updated 2024-10-09
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.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
PointCheck
Binary classification of severe neutropenia
Sponsors & Collaborators
-
Leuko Labs, Inc.
lead INDUSTRY
Principal Investigators
-
Carlos Castro Gonzalez, PhD · Leuko Labs
Eligibility
- Min Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-01
- Primary Completion
- 2026-03-30
- Completion
- 2026-04-28
- FDA Device
- Yes
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