Entia Liberty: Accuracy and Precision

Completed

• Conditions: Cancer
• Interventions: Device: Entia Liberty

• Registration Number: NCT05025124
• Lead Sponsor: Entia Ltd

Brief Summary

This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's performance claims with venous blood compared to the gold standard clinical laboratory haematology analysers. Excess blood flagged by the laboratory meeting our requirements will be tested on the Entia Liberty device and have its results compared against the laboratory results. Samples will also be flagged for precision testing (same blood sample, split into 10 Entia Liberty samples).

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: 2022-10-03
• Primary Completion: 2022-12-14
• Study Completion: 2022-12-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

• Age >18 years old
• 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
• Blood samples that have been stored in K2-EDTA vacutainers only
• For Accuracy testing: Samples covering 75% of parameter ranges (Neutrophils: 0.5-7.5 x 109/L, Platelets: 20-450 x 109/L, Haemoglobin: 70-180 g/L), These will be determined by a gold standard analyser which has been recently calibrated.
• Reliability study: Level range per parameter. These will be determined by a gold standard analyser which has been recently calibrated.
• Neutrophils (We assume WBC to behave similarly in the same ranges) Low: 0.5-1.2 x 109/L (3 samples), 1.2-2 x 109/L (2 samples) Normal: 2-7 x 109/L (3-4 samples) High: 7-12 x 109/L (1-2 samples)
• Platelets Low: 50-150 x 109/L (5 samples) Normal: 150-400 x 109/L (3 - 4 samples) High: >400 x 109/L (1-2 samples)
• Haemoglobin Low: <120 g/L (5 samples) Normal: 120-170 g/L (3 - 4 samples) High: >170 g/L (1-2 samples)

Exclusion Criteria

• History of haematological malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Precision	Entia Liberty	30 samples will be each split into 10 individual samples to evaluate the precision of the Entia Liberty devices.
Method comparison	Entia Liberty	400 samples to be compared directly against the reference method. This is to get the bias estimate.

Primary Outcome Measures

Name	Time	Method
To obtain the Total Error per parameter from the results of the Entia Liberty device	3 months	The dataset from this study will provide evidence to support the device's performance claims.
To obtain the precision per parameter from the results of the Entia Liberty device	3 months	The dataset from this study will provide evidence to support the device's performance claims.
To obtain the bias per parameter from the results of the Entia Liberty device	3 months	The dataset from this study will provide evidence to support the device's performance claims.
To obtain the linearity per parameter from the results 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 (1)

Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom