Entia Liberty: Capillary Validation

Entia Liberty: Clinical Performance Validation - Capillary Performance

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05025111

Enrollment

150

Registered

2021-08-27

Start date

2022-09-12

Completion date

2022-10-26

Last updated

2023-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

DEVICEEntia Liberty

Home monitoring device

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
To obtain/validate the value of the total error of the Entia Liberty device.	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.	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.	3 months	The dataset from this study will provide evidence to support the device's performance claims.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026