Serial Blood Count Study

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT07066085
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Congenital Neutropenia
  • Cyclic Neutropenia
  • Neutropenia

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Serial Blood Count Study — 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.
  • Athelas Home device — 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.

Study Details

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.

Key Dates

Start date
Oct 17, 2024
Status verified
Jul 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Serial Blood Count Study

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington Medical Center - MontlakeSeattleWashington98195
David C. Dale, MD
[email protected]
206-543-7215
Audrey Anna Bolyard, RN, BSN
[email protected]
206-543-7218
David C. Dale, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Washington Medical Center - Montlake· Seattle, WA

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