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

Sponsor
Leuko Labs, Inc.
Study ID
NCT06323447
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PointCheck — DIAGNOSTIC_TEST
    Binary classification of severe neutropenia

Study Details

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.

Key Dates

First listed
Mar 21, 2024
Start date
Apr 1, 2025
Status verified
Oct 2024
Primary completion
Mar 30, 2026
Completion
Apr 28, 2026

Study Design

Enrollment
210 participants (estimated)

Primary Outcome Measure

PointCheck Accuracy [ Time Frame: Two weeks ]

Central Contacts

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