Investigation of the Usability of Neutrocheck Amongst Healthy Volunteers and Healthcare Professionals. (NeutroUSE)

52 North Health

Status: Not yet enrolling

Conditions: Neutropenic Sepsis (Disorder); Neutropenia, Febrile; Neutropenia

Study type: Observational

Funder types: Industry

Identifiers

NCT05852249

NeutroUSE

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provide informed consent to participate
• Age 18 years or over

Exclusion criteria

• Known HIV or active Hep B or Hep C infection
• Phobia of needles or blood
• Currently undergoing immunosuppressive medical treatment or have received immunosuppressive treatment in the previous 3 months.

Trial design

60 participants in 2 patient groups

Paper instruction

Description:

Participants in this group will use paper instructions to use Neutrocheck.

App instruction

Description:

Participants in this group will use App instructions to use Neutrocheck.