Athelas Home Device for Cyclic Neutropenia

This trial tests a new home device called Athelas One, which monitors white blood cells to diagnose cyclic neutropenia—a condition characterized by low levels of neutrophils, a type of white blood cell. The goal is to determine if this device can distinguish between cyclic neutropenia and a similar condition, severe congenital neutropenia. Individuals diagnosed with severe chronic neutropenia and possessing a specific gene mutation (known as ELANE) may be suitable for this trial. Participants must have internet access and a smartphone to use the device. As an Early Phase 1 trial, this research aims to understand how the device functions in people, offering participants the opportunity to be among the first to use this innovative technology.

The trial information does not specify whether you need to stop taking your current medications.

Research has shown that the Athelas Home device has received FDA clearance as a Class 2 device, indicating its safety for checking white blood cell (WBC) and absolute neutrophil counts (ANC). The device targets patients with neutropenia, a condition characterized by a low count of neutrophils, a type of white blood cell.

The Athelas Home device is unique because it offers a convenient, at-home solution for managing cyclic neutropenia by allowing patients to monitor their blood counts regularly without frequent hospital visits. Unlike standard treatments that primarily involve regular injections or infusions, this device simplifies the process through a user-friendly, portable system that provides real-time data. Researchers are excited about this device because it empowers patients with more control over their condition and potentially improves their quality of life by reducing the burden of frequent clinical appointments.

Research has shown that the Athelas Home device helps users check white blood cell (WBC) and neutrophil levels with a simple fingerprick test. The FDA has cleared this device, confirming its safety and effectiveness for its intended use. Early findings suggest it could simplify health monitoring at home for individuals with neutropenia, a condition characterized by low levels of certain white blood cells. This can aid in identifying conditions like cyclic neutropenia and distinguishing them from more serious forms. By enabling regular check-ups, the Athelas device provides crucial information that can guide treatment decisions. Participants in this trial will use the Athelas Home device as part of the Serial Blood Count Study to evaluate its effectiveness in monitoring cyclic neutropenia.¹²⁶⁷⁸