Entia Liberty: Capillary Validation

Entia

Status: Completed

Conditions: Cancer

Treatments: Device: Entia Liberty

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05025111

304718

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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