Recruiting

Early Phase 1

Athelas OneSerial Blood Count Study

Sponsor:

University of Washington

Code:

NCT07066085

Conditions

Cyclic Neutropenia

Congenital Neutropenia

Neutropenia

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Interventions

Serial Blood Count Study

Athelas Home device

Study Details

Brief summary:

The objective of the Serial Blood Count Study is to determine the utility of home monitoring of white blood cell (WBC) and absolute neutrophil counts (ANC) to diagnose cyclic neutropenia and distinguish between cyclic and severe congenital neutropenia (SCN). A new home monitoring device called Athelas One was granted an FDA 510K Class 2 clearance for evaluation of white blood count (WBC) and absolute neutrophil count (ANC). The investigators believe this device provides a unique and extremely valuable opportunity to for diagnosis of these diseases.

Conditions

Cyclic Neutropenia

Congenital Neutropenia

Neutropenia

Study ID

NCT07066085

Start date

Oct 17, 2024

Status verified date

Jul, 2025

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Serial Blood Count Study

Interventions

Serial Blood Count Study

A new home monitoring device called Athelas One (or Athelas Home) was granted an FDA 510K Class 2 clearance for evaluation of white blood count (WBC) and absolute neutrophil count (ANC).

The device uses a drop of blood on a slide to measure the WBC and ANC. The drop of blood is obtained using a lancet that comes with the device, it is just like how diabetics do with a glucose monitoring device. The process will be done once a day for 42 days (6 weeks) unless the drop is not placed on the slide correctly. If there is an issue with the first attempt, the process could be done again to obtain the WBC and ANC results.

The Athelas device is intended for use by patients with neutropenia or patients at risk of neutropenia. The device is indicated for use by patients and caregivers within home settings with results viewable by health care professionals.

Athelas Home device

Primary outcome measure

Test feasibility of device for white blood cell (WBC) count [ Time Frame: Daily blood counts over a period of 42 days (6 weeks) ]

Central Contacts and Locations

Central contacts

Audrey Anna Bolyard, RN, BSN

206-543-7218 bolyard@uw.edu

David C. Dale, MD

206-543-7215 dcdale@uw.edu

Locations

University of Washington Medical Center - Montlake

Recruiting

Seattle, Washington, United States, 98195

Contacts

David C. Dale, MD

206-543-7215 dcdale@uw.edu

Audrey Anna Bolyard, RN, BSN

206-543-7218 bolyard@uw.edu

Principal Investigator:

David C. Dale, MD

More Information

Sponsor

University of Washington

Last update posted

Jul 15, 2025

Last verified

Jul, 2025

Keywords

Neutropenia
Cyclic Neutropenia
Congenital Neutropenia
Device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2025-07-15.