Entia Liberty: Accuracy and Precision

NCT ID: NCT05025124

Last Updated: 2023-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

530 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-03

Study Completion Date

2022-12-14

Brief Summary

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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

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Conditions

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Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Method comparison

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

Entia Liberty

Intervention Type DEVICE

Home monitoring system

Precision

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

Entia Liberty

Intervention Type DEVICE

Home monitoring system

Interventions

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Entia Liberty

Home monitoring system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Entia Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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304727

Identifier Type: -

Identifier Source: org_study_id

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