Entia Liberty: Capillary Validation
Entia Liberty: Clinical Performance Validation - Capillary Performance
1 other identifier
observational
150
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2022
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedStudy Start
First participant enrolled
September 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2022
CompletedJanuary 27, 2023
January 1, 2023
1 month
August 26, 2021
January 26, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
3 months
Interventions
Home monitoring device
Eligibility Criteria
Participants will be recruited from the outpatients clinic at the Christie, while they are waiting for their blood tests.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Entia Ltdlead
- The Christie NHS Foundation Trustcollaborator
Study Sites (2)
The Christie NHS Foundation Trust
Manchester, United Kingdom
Royal Albert Edward Infirmary
Wigan, United Kingdom
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2021
First Posted
August 27, 2021
Study Start
September 12, 2022
Primary Completion
October 26, 2022
Study Completion
October 26, 2022
Last Updated
January 27, 2023
Record last verified: 2023-01