Serial Blood Count Study for Neutropenia

This study is testing a new home monitoring device called Athelas One (or Athelas Home) to measure white blood cell (WBC) and absolute neutrophil count (ANC) from a drop of blood. The goal is to see how well this device can help doctors tell the difference between cyclic neutropenia and severe congenital neutropenia (SCN), which are conditions where you have too few neutrophils (a type of white blood cell). You can join if you are 5 years or older, have a confirmed diagnosis of severe chronic neutropenia, and have a known ELANE gene mutation. The study will be successful if the device is shown to be practical for daily blood counts over 42 days. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 20 participants. It is designed to test the feasibility of a home monitoring device.
What's involved
You would take daily blood counts using the Athelas One device over a period of 42 days (6 weeks). You will also need a computer, internet access, and a smartphone to download an app.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT07066085

Serial Blood Count Study

Recruiting
EARLY_PHASE1Ages 5+InterventionalDiagnostic
University of Washington
~20 participants
Updated 2025-07-15 on ClinicalTrials.gov
What's tested:Serial Blood Count StudyAthelas Home device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Test feasibility of device for white blood cell (WBC) count
Measured over Daily blood counts over a period of 42 days (6 weeks)
Cyclic Neutropenia
Congenital Neutropenia
Neutropenia
1 sites across 1 states
Washington1
  • David C. Dale, MD · PRINCIPAL_INVESTIGATOR · University of Washington

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Eligibility criteria

Inclusion

Confirmed diagnosis of severe chronic neutropenia
5 years of age or older, male or female
Known positive ELANE mutation
Computer if available
Internet access
Cell phone / Smart phone that can download / install applications (App)
Adults that are comfortable obtaining the samples without medical conditions that would make collection of the sample difficult.

Exclusion

Diagnosis of severe chronic neutropenia and negative results for the ELANE mutation
Less than 5 years of age
No internet access
No Cell phone or smart phone that cannot download / install applications (App)
Adults that are uncomfortable obtaining the samples or have medical conditions that would make collection of the sample difficult.
  • Test feasibility of device for white blood cell (WBC) countDaily blood counts over a period of 42 days (6 weeks)