Entia Liberty: Usability Validation

Entia

Status: Completed

Conditions: Cancer

Treatments: Device: Entia Liberty

Study type: Observational

Funder types: Industry

Identifiers

NCT05027256

304701

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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
• 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