NeutropeniaNeutroUSENCT05852249
Investigation of the Usability of Neutrocheck Amongst Healthy Volunteers and Healthcare Professionals.
An observational study of Neutropenia and Neutropenia, Febrile, run by 52 North Health Ltd.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neutropenia, Neutropenia, Febrile, Neutropenic Sepsis (Disorder)
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Provide informed consent to participate
- Age 18 years or over
Who cannot join
- 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.
About this study
Official title: Neutrocheck Summative Usability Study
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.
Read more
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.
- Medical subject headings
- Neutropenia, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Paper instruction | Participants in this group will use paper instructions to use Neutrocheck. | |
| App instruction | Participants in this group will use App instructions to use Neutrocheck. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of use errors, close calls and use difficulties associated with selected hazard-related use scenarios and participant's perceived root causes of these.
Measured: 2 months
Administration of a questionnaire to assess the effectiveness of key information for safety.
Participants will be asked to complete a questionnaire consisting of multiple choice questions related to key safety information for use of Neutrocheck. For example, this includes questions on storage of the device, expiry date and when to contact a healthcare professional. The data collected from the questionnaire will be summarised using descriptive statistics.
Measured: 2 months
Secondary outcomes (3)
Administration of a questionnaire to measure user satisfaction with the use of Neutorcheck
Participants will be asked to complete a questionnaire consisting of interval questions related to user satisfaction following use of Neutrocheck. The data collected from the questionnaire will be summarised using descriptive statistics.
Measured: 2 months
Comparison of descriptive statistics for task completion rates, measured through observation, between two study groups, one using paper instructions and the other using app instructions.
Fisher's exact test will be used to determine the statistical significance of the differences in mean values between the two groups. To perform this analysis, we will utilise a statistical software such as R.
Measured: 2 months
Comparison of user satisfaction, measured through a questionnaire, between two study groups: one group using paper instructions and the other using app instructions.
Fisher's exact test will be used to determine the statistical significance of the differences in mean values of responses between the two study groups completing the questionnaire. To perform this analysis, we will utilise a statistical software such as R.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study startAug 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 52 North Health Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852249
- Sponsor's protocol ID
- NeutroUSE
- Acronym
- NeutroUSE
- Status last verified
- May 2023
- First submitted
- 19 Apr 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrocheck Summative Usability Study
- ClinicalTrials.gov ID
- NCT05852249
- Acronym / sponsor ID
- NeutroUSE / NeutroUSE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- 52 North Health LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paper instruction | – | –Participants in this group will use paper instructions to use Neutrocheck. |
| App instruction | – | –Participants in this group will use App instructions to use Neutrocheck. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- Provide informed consent to participate
- Age 18 years or over
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of use errors, close calls and use difficulties associated with selected hazard-related use scenarios and participant's perceived root causes of these.
Time frame: 2 months
Administration of a questionnaire to assess the effectiveness of key information for safety.
Time frame: 2 months
Participants will be asked to complete a questionnaire consisting of multiple choice questions related to key safety information for use of Neutrocheck. For example, this includes questions on storage of the device, expiry date and when to contact a healthcare professional. The data collected from the questionnaire will be summarised using descriptive statistics.
3 secondary outcomes
Administration of a questionnaire to measure user satisfaction with the use of Neutorcheck
Time frame: 2 months
Comparison of descriptive statistics for task completion rates, measured through observation, between two study groups, one using paper instructions and the other using app instructions.
Time frame: 2 months
Comparison of user satisfaction, measured through a questionnaire, between two study groups: one group using paper instructions and the other using app instructions.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neutropenia and Neutropenia, Febrile, run by 52 North Health Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of use errors, close calls and use difficulties associated with selected hazard-related use scenarios and participant's perceived root causes of these. (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.