CancerNCT05027256
Entia Liberty: Usability Validation
An observational study of Cancer, run by Entia Ltd at 2 sites in United Kingdom.
Trial summary
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's validation of the device. Participants will be trained to take an Entia Liberty test in a simulated home environment and a trained healthcare professional will perform another test from the same… 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
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 12 Sep 2022to 30 Nov 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 recruited from the outpatients clinic at the Christie
Who may be able to join
- Age >18 years old at the time of study entry
- Can provide written informed consent
- Patients who are currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and have received at least one cycle
- Sufficient hearing to be able to participate in a video training session
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
- Participant unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
- Previously taken part in the 'PERTH-2' study involving a prototype device
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Buckinghamshire Healthcare NHS Trust
Aylesbury
The Christie NHS Foundation Trust
Manchester
About this study
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's validation of the device. Participants will be trained to take an Entia Liberty test in a simulated home environment and a trained healthcare professional will perform another test from the same participant (different finger) on a separate device. The results will be compared. Usability data will be observed and the participants will complete a questionnaire after the tests have been performed.
- 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 solution
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants able to use the Entia Liberty device as specified in the validation procedure is 80%.
At least 24 of the participants are able to complete the Entia Liberty test.
Measured: 3 months
Number of participants with new severe usability problems identified.
Identification of the number of participants that were deviating away from the instructions for use, resulting in increased risk to the results or themselves
Measured: 3 months
Number of participants with study-related adverse events as assessed by the Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)
Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)
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 posted30 Aug 2021
- Study start12 Sep 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 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
- 30 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
- NCT05027256
- Sponsor's protocol ID
- 304701
- Status last verified
- Jan 2023
- First submitted
- 26 Aug 2021
- Last updated
- 27 Jan 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 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entia Liberty: Usability Validation
- ClinicalTrials.gov ID
- NCT05027256
- Acronym / sponsor ID
- 304701
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Entia LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 30 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 forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's validation of the device. Participants will be trained to take an Entia Liberty test in a simulated home environment and a trained healthcare professional will perform another test from the same participant (different finger) on a separate device. The results will be compared. Usability data will be observed and the participants will complete a questionnaire after the tests have been performed.
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 recruited from the outpatients clinic at the Christie
Key inclusion criteria (4 listed)
- Age >18 years old at the time of study entry
- Can provide written informed consent
- Patients who are currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and have received at least one cycle
- Sufficient hearing to be able to participate in a video training session
Key exclusion criteria (6 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
- Participant unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
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 solution | Device | – |
Primary outcome
Number of participants able to use the Entia Liberty device as specified in the validation procedure is 80%.
Time frame: 3 months
At least 24 of the participants are able to complete the Entia Liberty test.
Number of participants with new severe usability problems identified.
Time frame: 3 months
Identification of the number of participants that were deviating away from the instructions for use, resulting in increased risk to the results or themselves
Number of participants with study-related adverse events as assessed by the Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)
Time frame: 3 months
Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)
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 4 inclusion and 6 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?
Number of participants able to use the Entia Liberty device as specified in the validation procedure is 80%. (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.