[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598022":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":23,"centralContacts":27,"locations":36,"responsibleParty":55,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":9,"officialTitle":9,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":60,"sex":63,"minAge":64,"maxAge":11,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University of Washington","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Serial Blood Count Study","EXPERIMENTAL",null,[13,14],"Device: Serial Blood Count Study","Device: Athelas Home device",[16,20],{"type":17,"name":9,"description":18,"armGroupLabels":19,"otherNames":11},"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).\n\nThe 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.\n\nThe 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.",[9],{"type":17,"name":21,"description":18,"armGroupLabels":22,"otherNames":11},"Athelas Home device",[9],[24],{"name":25,"affiliation":5,"role":26},"David C. Dale, MD","PRINCIPAL_INVESTIGATOR",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Audrey Anna Bolyard, RN, BSN","CONTACT","206-543-7218","bolyard@uw.edu",{"name":25,"role":30,"phone":34,"phoneExt":11,"email":35},"206-543-7215","dcdale@uw.edu",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University of Washington Medical Center - Montlake","RECRUITING","Seattle","Washington","98195","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-122.33207,47.60621,{"lat":49,"lon":48},[52,53,54],{"name":25,"role":30,"phone":34,"phoneExt":11,"email":35},{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},{"name":25,"role":26,"phone":11,"phoneExt":11,"email":11},{"type":26,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"David Dale","Professor, Division of Internal Medicine","100598022","early-phase-1-serial-blood-count-study-100598022",false,"NCT07066085","Inclusion Criteria:\n\n* Confirmed diagnosis of severe chronic neutropenia\n* 5 years of age or older, male or female\n* Known positive ELANE mutation\n* Computer if available\n* Internet access\n* Cell phone \u002F Smart phone that can download \u002F install applications (App)\n* Adults that are comfortable obtaining the samples without medical conditions that would make collection of the sample difficult.\n\nExclusion Criteria:\n\n* Diagnosis of severe chronic neutropenia and negative results for the ELANE mutation\n* Less than 5 years of age\n* No internet access\n* No Cell phone or smart phone that cannot download \u002F install applications (App)\n* Adults that are uncomfortable obtaining the samples or have medical conditions that would make collection of the sample difficult.","ALL","5 Years",{"count":66,"type":67},20,"ESTIMATED","INTERVENTIONAL",[70],"EARLY_PHASE1","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.",[73,74,75],"Cyclic Neutropenia","Congenital Neutropenia","Neutropenia",[75,73,74,77],"Device","2025-07-03",{"date":80,"type":81},"2025-07-15","ACTUAL",{"date":83,"type":81},"2024-10-17",{"date":85,"type":67},"2025-12-01",{"name":5,"class":6},1]