CancerNCT05462288
Entia Liberty: Home Study
An observational study of Cancer, run by Entia Ltd at 1 site in United Kingdom.
Trial summary
Participants will be testing with the home monitoring device over the course of their treatment. They are to self-test on days where they are due to be going into hospital for their routine pre-treatment blood tests. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Entia Liberty
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2023to 5 Dec 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
- No healthy volunteers
- Adult, Older adult
Study population: New or existing patients on specific drug treatments recruited by their consultants
Who may be able to join
- Age ≥ 18
- Adequate English language skills (not requiring a translator) to participate in participant training and use the Liberty device
- Patients willing and able to perform capillary blood self-testing at the same frequency as routine full blood count monitoring
- Patients capable of providing informed consent before attending training
- Patients able to attend a 1-hour virtual training session within 2 weeks of joining the study
- Patients with a home Wi-Fi network or with adequate coverage at home via a 4G network
Show all 9Show fewer
- Patients with access to a laptop or smartphone to facilitate training
- Patients with a diagnosis of ovarian or breast cancer
- Patients whose HCPs can confirm are undergoing systemic anti-cancer treatments within two weeks of enrolment, with treatment expected to continue for at least two cycles
Who cannot join
- Patients with haematological malignancies
- Patients with eyesight or hearing limitations or other disabilities that preclude the use of the Liberty device or participation in training unless they have a nominated caregiver who is capable of assisting with each test
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Official title: Entia Liberty: Home Study - Evaluation of Patient Preference for a Novel Full Blood Count Home Testing Device Versus Routine Venous Monitoring
Participants will be testing with the home monitoring device over the course of their treatment. They are to self-test on days where they are due to be going into hospital for their routine pre-treatment blood tests. Participants will be asked to fill in interim questionnaires and a final questionnaire to answer the study objectives.
- Conditions
- Cancer
- Being tested
- Entia Liberty
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entia LibertyDevice
Home monitoring blood analyser
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | Not described Receives: Device: Entia Liberty |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess patient preference for the Liberty self-testing pathway as compared to standard of care.
Patients will undergo the study procedures without change to their current pathway, at the end of the study, patients will compare the interventions via a SURVEY. The investigators will measure the success of the comparison by the % of patients who have chosen the investigators' product over the standard of care (4-5 rating out of 5).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start6 Jan 2023
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462288
- Sponsor's protocol ID
- 317614
- Status last verified
- Mar 2024
- First submitted
- 20 Jun 2022
- Last updated
- 13 Mar 2024
- 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 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entia Liberty: Home Study - Evaluation of Patient Preference for a Novel Full Blood Count Home Testing Device Versus Routine Venous Monitoring
- ClinicalTrials.gov ID
- NCT05462288
- Acronym / sponsor ID
- 317614
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Entia LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 18 Jul 2022 (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.
Participants will be testing with the home monitoring device over the course of their treatment. They are to self-test on days where they are due to be going into hospital for their routine pre-treatment blood tests. Participants will be asked to fill in interim questionnaires and a final questionnaire to answer the study objectives.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | Device: Entia Liberty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- New or existing patients on specific drug treatments recruited by their consultants
Key inclusion criteria (9 listed)
- Age ≥ 18
- Adequate English language skills (not requiring a translator) to participate in participant training and use the Liberty device
- Patients willing and able to perform capillary blood self-testing at the same frequency as routine full blood count monitoring
- Patients capable of providing informed consent before attending training
- Patients able to attend a 1-hour virtual training session within 2 weeks of joining the study
Key exclusion criteria (2 listed)
- Patients with haematological malignancies
- Patients with eyesight or hearing limitations or other disabilities that preclude the use of the Liberty device or participation in training unless they have a nominated caregiver who is capable of assisting with each test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entia LibertyHome monitoring blood analyser | Device | Patient Group |
Primary outcome
To assess patient preference for the Liberty self-testing pathway as compared to standard of care.
Time frame: 12 months
Patients will undergo the study procedures without change to their current pathway, at the end of the study, patients will compare the interventions via a SURVEY. The investigators will measure the success of the comparison by the % of patients who have chosen the investigators' product over the standard of care (4-5 rating out of 5).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Entia Ltd at 1 site in United Kingdom.
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 9 inclusion and 2 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: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess patient preference for the Liberty self-testing pathway as compared to standard of care. (time frame: 12 months). 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 Mar 2024.