Entia Liberty: Accuracy and Precision

January 26, 2023 updated by: Entia Ltd

Entia Liberty: Analytical Performance Validation - 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

530

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom
        • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Method comparison
400 samples to be compared directly against the reference method. This is to get the bias estimate.
Device: Entia Liberty
Home monitoring system
Precision
30 samples will be each split into 10 individual samples to evaluate the precision of the Entia Liberty devices.
Device: Entia Liberty
Home monitoring system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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 months
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Entia Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2022

Primary Completion (Actual)

December 14, 2022

Study Completion (Actual)

December 14, 2022

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 304727

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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