Entia Liberty: Usability Validation

January 26, 2023 updated by: Entia Ltd
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's validation of the device. Participants will be trained to take an Entia Liberty test in a simulated home environment and a trained healthcare professional will perform another test from the same participant (different finger) on a separate device. The results will be compared. Usability data will be observed and the participants will complete a questionnaire after the tests have been performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

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
      • Aylesbury, United Kingdom
        • Buckinghamshire Healthcare NHS Trust
      • Manchester, United Kingdom
        • The Christie NHS Foundation 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

Participants recruited from the outpatients clinic at the Christie

Description

Inclusion Criteria:

  • Age >18 years old at the time of study entry
  • Can provide written informed consent
  • Patients who are currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and have received at least one cycle
  • Sufficient hearing to be able to participate in a video training session

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
  • Participant unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
  • Previously taken part in the 'PERTH-2' study involving a prototype device

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
Number of participants able to use the Entia Liberty device as specified in the validation procedure is 80%.
Time Frame: 3 months
At least 24 of the participants are able to complete the Entia Liberty test.
3 months
Number of participants with new severe usability problems identified.
Time Frame: 3 months
Identification of the number of participants that were deviating away from the instructions for use, resulting in increased risk to the results or themselves
3 months
Number of participants with study-related adverse events as assessed by the Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)
Time Frame: 3 months
Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)
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)

September 12, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

August 30, 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

  • 304701

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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