NeutroUSE

• Research type

  Research Study

• Full title

  Neutrocheck summative usability study.

• IRAS ID

  327955

• Contact name

  Saif Ahmad

• Contact email

  saif@52north.health

• Sponsor organisation

  52 North Health

• Clinicaltrials.gov Identifier

  NCT05852249

• Duration of Study in the UK

  0 years, 1 months, 31 days

• Research summary

  This study proposes to assess the usability of the Neutrocheck device and test kit amongst healthy volunteers and healthcare professionals (HCPs).
  Neutrocheck is a portable, single-use diagnostic test intended to aid the diagnosis of neutropenia, febrile neutropenia and neutropenic sepsis using a finger prick blood sample.
  Neutropenia is when the number of infection-fighting neutrophil cells in the blood are lower than normal. It can be caused by treatments such as chemotherapy or by certain medical conditions. Neutropenic sepsis is a life-threatening medical emergency that occurs when patients with neutropenia develop an infection. There is currently no way to test for neutropenic sepsis outside of hospitals. Neutrocheck is being developed for use as a self-test by patients at home alongside remote consultation with a HCP or at point-of-care by a HCP. This will allow rapid identification of patients requiring urgent intravenous antibiotics and medical assessment. In cases where Neutrocheck has eliminated the possibility of neutropenic sepsis, patients can avoid unnecessary and stressful hospital visits and valuable hospital resources will be saved.
  Participants in this study will be invited to use the Neutrocheck test kit in a setting similar to a home environment to carry out a test, whilst being observed by a study moderator. The Neutrocheck devices used in the study will be for investigational use only. This study will not be testing the accuracy of the Neutrocheck result, rather if Neutrocheck can be used safely and in a user-friendly way. Results will not be considered valid. Planned study duration is 2 months. This approach will enable us to complete the current phase of development and advance to a clinical validation study of Neutrocheck, assessing the diagnostic accuracy of Neutrocheck amongst users including those at risk of neutropenia and neutropenic sepsis.

• REC name

  South East Scotland REC 02

• REC reference

  23/SS/0061

• Date of REC Opinion

  25 May 2023

• REC opinion

  Further Information Favourable Opinion