Trials / Not Yet Recruiting
Not Yet RecruitingNCT06323447
Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
Pivotal Study to Validate the Usability, Safety and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 210 (estimated)
- Sponsor
- Leuko Labs, Inc. · Industry
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | PointCheck | Binary classification of severe neutropenia |
Timeline
- Start date
- 2025-04-01
- Primary completion
- 2026-03-30
- Completion
- 2026-04-28
- First posted
- 2024-03-21
- Last updated
- 2024-10-09
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06323447. Inclusion in this directory is not an endorsement.