CancerNCT05025111
Entia Liberty: Capillary Validation
An observational study of Cancer, run by Entia Ltd at 2 sites in United Kingdom.
Trial summary
This study is a clinical performance validation study to evaluate the performance of the Entia Liberty device. Patients undergoing routine venepuncture blood tests will be recruited to have an Entia Liberty test (by finger-prick) done on them by a trained healthcare professional. 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
- 150 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 12 Sep 2022to 26 Oct 2022
- 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: Participants will be recruited from the outpatients clinic at the Christie, while they are waiting for their blood tests.
Who may be able to join
- Age >18 years old at the time of study entry
- Currently receiving standard of care systemic anti- cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle.
- Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
- Can provide written informed consent
- Blood samples collected and stored in K2-EDTA vacutainers only
Who cannot join
- Known inherited or acquired bleeding disorder
- History of haematological malignancy
- Known poorly controlled anti-coagulation
- Inadequate use and understanding of the English language, requiring a translator
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Christie NHS Foundation Trust
Manchester
Royal Albert Edward Infirmary
Wigan
About this study
Official title: Entia Liberty: Clinical Performance Validation - Capillary Performance
This study is a clinical performance validation study to evaluate the performance of the Entia Liberty device. Patients undergoing routine venepuncture blood tests will be recruited to have an Entia Liberty test (by finger-prick) done on them by a trained healthcare professional. The results from that finger-prick test will be compared against the results from the routine venepuncture blood test (reference method) and subsequently, excess blood from the routine venepuncture test will be run on another Entia Liberty device in the laboratory. All three results (Entia Liberty capillary, Entia Liberty venous and gold standard venous) will be compared against each other to prove Entia Liberty's performance claims.
- 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 device
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain/validate the value of the total error of the Entia Liberty device.
The dataset from this study will provide evidence to support the device's performance claims.
Measured: 3 months
To obtain/validate the value of the linearity of the Entia Liberty device.
The dataset from this study will provide evidence to support the device's performance claims.
Measured: 3 months
To obtain/validate the value of the bias of the Entia Liberty device.
The dataset from this study will provide evidence to support the device's performance claims.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start12 Sep 2022
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Christie NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025111
- Sponsor's protocol ID
- 304718
- Status last verified
- Jan 2023
- First submitted
- 26 Aug 2021
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entia Liberty: Clinical Performance Validation - Capillary Performance
- ClinicalTrials.gov ID
- NCT05025111
- Acronym / sponsor ID
- 304718
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Entia LtdIndustry (pharma, biotech, devices)
- Collaborators
- The Christie NHS Foundation Trust
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 27 Aug 2021 (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 is a clinical performance validation study to evaluate the performance of the Entia Liberty device. Patients undergoing routine venepuncture blood tests will be recruited to have an Entia Liberty test (by finger-prick) done on them by a trained healthcare professional. The results from that finger-prick test will be compared against the results from the routine venepuncture blood test (reference method) and subsequently, excess blood from the routine venepuncture test will be run on another Entia Liberty device in the laboratory. All three results (Entia Liberty capillary, Entia Liberty venous and gold standard venous) will be compared against each other to prove Entia Liberty's performance claims.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the outpatients clinic at the Christie, while they are waiting for their blood tests.
Key inclusion criteria (5 listed)
- Age >18 years old at the time of study entry
- Currently receiving standard of care systemic anti- cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle.
- Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
- Can provide written informed consent
- Blood samples collected and stored in K2-EDTA vacutainers only
Key exclusion criteria (4 listed)
- Known inherited or acquired bleeding disorder
- History of haematological malignancy
- Known poorly controlled anti-coagulation
- Inadequate use and understanding of the English language, requiring a translator
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 device | Device | – |
Primary outcome
To obtain/validate the value of the total error of the Entia Liberty device.
Time frame: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
To obtain/validate the value of the linearity of the Entia Liberty device.
Time frame: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
To obtain/validate the value of the bias of the Entia Liberty device.
Time frame: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
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 27 Jan 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.
2 sites 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 2 sites 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 5 inclusion and 4 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 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 obtain/validate the value of the total error of the Entia Liberty device. (time frame: 3 months). The study lists 3 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 27 Jan 2023; AzTrials last refreshed its copy on 4 Nov 2026.