Entia Liberty: Accuracy and Precision

Cancer Clinical Trial

Official title:

Entia Liberty: Analytical Performance Validation - Accuracy and Precision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05025124
• Other study ID #: 304727
• Status: Completed
• Start date: October 3, 2022
• Est. completion date: December 14, 2022

Study information

• Verified date: January 2023
• Source: Entia Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• Entia Liberty
Home monitoring system

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Entia Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To obtain the Total Error per parameter from the results of the Entia Liberty device	The dataset from this study will provide evidence to support the device's performance claims.	3 months
Primary	To obtain the linearity per parameter from the results of the Entia Liberty device	The dataset from this study will provide evidence to support the device's performance claims.	3 months
Primary	To obtain the bias per parameter from the results of the Entia Liberty device	The dataset from this study will provide evidence to support the device's performance claims.	3 months
Primary	To obtain the precision per parameter from the results of the Entia Liberty device	The dataset from this study will provide evidence to support the device's performance claims.	3 months