Entia Liberty: Accuracy and Precision

NCT05025124 | Completed

• 1 other identifier: 304727
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Method comparison

400 samples to be compared directly against the reference method. This is to get the bias estimate.

Device: Entia Liberty

Precision

30 samples will be each split into 10 individual samples to evaluate the precision of the Entia Liberty devices.

Device: Entia Liberty

Interventions

Entia Liberty DEVICE

Home monitoring system

Method comparison; Precision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

No participants will be recruited. Samples used are from excess venous bloods from the Christie haematology laboratory

You may qualify if:

• 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)

You may not qualify if:

• History of haematological malignancy

Sponsors & Collaborators

• Entia Ltd: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: August 27, 2021
• Study Start: October 3, 2022
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

GB (1)