Entia Liberty: Capillary Validation

January 26, 2023 updated by: Entia Ltd

Entia Liberty: Clinical Performance Validation - Capillary Performance

This study is a clinical performance validation study to evaluate the performance of the Entia Liberty device. Patients undergoing routine venepuncture blood tests will be recruited to have an Entia Liberty test (by finger-prick) done on them by a trained healthcare professional. The results from that finger-prick test will be compared against the results from the routine venepuncture blood test (reference method) and subsequently, excess blood from the routine venepuncture test will be run on another Entia Liberty device in the laboratory. All three results (Entia Liberty capillary, Entia Liberty venous and gold standard venous) will be compared against each other to prove Entia Liberty's performance claims.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

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
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust
      • Wigan, United Kingdom
        • Royal Albert Edward Infirmary

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

Participants will be recruited from the outpatients clinic at the Christie, while they are waiting for their blood tests.

Description

Inclusion Criteria:

  • Age >18 years old at the time of study entry
  • 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.
  • Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
  • Can provide written informed consent
  • Blood samples collected and stored in K2-EDTA vacutainers only

Exclusion Criteria:

  • Known inherited or acquired bleeding disorder
  • History of haematological malignancy
  • Known poorly controlled anti-coagulation
  • Inadequate use and understanding of the English language, requiring a translator

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To obtain/validate the value of the total error 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/validate the value of the linearity 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/validate the value of the bias 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

Collaborators

The Christie NHS Foundation Trust

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)

September 12, 2022

Primary Completion (Actual)

October 26, 2022

Study Completion (Actual)

October 26, 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

  • 304718

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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