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NCT Number: NCT05025124

Entia Liberty: Accuracy and Precision

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).

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entia Liberty

Device

Home monitoring system

Primary outcomes

  1. To obtain the Total Error per parameter from the results of the Entia Liberty device

    Time frame: 3 months

    The dataset from this study will provide evidence to support the device's performance claims.

  2. To obtain the linearity per parameter from the results of the Entia Liberty device

    Time frame: 3 months

    The dataset from this study will provide evidence to support the device's performance claims.

  3. To obtain the bias per parameter from the results of the Entia Liberty device

    Time frame: 3 months

    The dataset from this study will provide evidence to support the device's performance claims.

  4. To obtain the precision per parameter from the results of the Entia Liberty device

    Time frame: 3 months

    The dataset from this study will provide evidence to support the device's performance claims.

Sponsors and collaborators

Lead sponsor

Entia Ltd

Industry

Registry information

Official study title

Entia Liberty: Analytical Performance Validation - Accuracy and Precision

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2021
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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