Serial Blood Count Study
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age5+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of severe chronic neutropenia
5 years of age or older, male or female
Known positive ELANE mutation
Computer if available
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Serial Blood Count Study
DeviceA 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
DeviceA 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Serial Blood Count StudyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Test feasibility of device for white blood cell (WBC) count
Time frame
Daily blood counts over a period of 42 days (6 weeks)Sponsors and contacts
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Source ClinicalTrials.gov