Entia Liberty: Capillary Validation

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Christie NHS Foundation Trust, Manchester, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entia Liberty

Device

Home monitoring device

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Entia Ltd

Industry

Collaborators

The Christie NHS Foundation Trust

Registry information

Official study title

Entia Liberty: Clinical Performance Validation - Capillary Performance

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Aug 27, 2021
Registry last updated: Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed