Serial Blood Count Study

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 17, 2024

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2025

Conditions
Cyclic NeutropeniaCongenital NeutropeniaNeutropenia
Interventions
DEVICE

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."

DEVICE

Athelas Home device

"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."

Trial Locations (1)

98195

RECRUITING

University of Washington Medical Center - Montlake, Seattle

All Listed Sponsors
lead

University of Washington

OTHER