Entia Liberty: Capillary Validation

Completed

• Conditions: Cancer

• Registration Number: NCT05025111
• Lead Sponsor: Entia Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-08-27
• Study Start: 2022-09-12
• Primary Completion: 2022-10-26
• Study Completion: 2022-10-26
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (2)

Royal Albert Edward Infirmary; 🇬🇧 Wigan, United Kingdom

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom