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Completed

NCT Number: NCT05027256

Entia Liberty: Usability Validation

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Buckinghamshire Healthcare NHS Trust, Aylesbury, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Entia Liberty

Device

Home Monitoring solution

Primary outcomes

  1. 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.

  2. 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. 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)

Sponsors and collaborators

Lead sponsor

Entia Ltd

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 30, 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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