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OpenTrials
Completed

NCT Number: NCT05462288

Entia Liberty: Home Study

Participants will be testing with the home monitoring device over the course of their treatment. They are to self-test on days where they are due to be going into hospital for their routine pre-treatment blood tests. Participants will be asked to fill in interim questionnaires and a final questionnaire to answer the study objectives.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18
  • Adequate English language skills (not requiring a translator) to participate in participant training and use the Liberty device
  • Patients willing and able to perform capillary blood self-testing at the same frequency as routine full blood count monitoring
  • Patients capable of providing informed consent before attending training
  • Patients able to attend a 1-hour virtual training session within 2 weeks of joining the study
  • Patients with a home Wi-Fi network or with adequate coverage at home via a 4G network
  • Patients with access to a laptop or smartphone to facilitate training
  • Patients with a diagnosis of ovarian or breast cancer
  • Patients whose HCPs can confirm are undergoing systemic anti-cancer treatments within two weeks of enrolment, with treatment expected to continue for at least two cycles

Exclusion criteria

  • Patients with haematological malignancies
  • Patients with eyesight or hearing limitations or other disabilities that preclude the use of the Liberty device or participation in training unless they have a nominated caregiver who is capable of assisting with each test

Treatment and study plan

Entia Liberty

Device

Home monitoring blood analyser

Primary outcomes

  1. To assess patient preference for the Liberty self-testing pathway as compared to standard of care.

    Time frame: 12 months

    Patients will undergo the study procedures without change to their current pathway, at the end of the study, patients will compare the interventions via a SURVEY. The investigators will measure the success of the comparison by the % of patients who have chosen the investigators' product over the standard of care (4-5 rating out of 5).

Sponsors and collaborators

Lead sponsor

Entia Ltd

Industry

Registry information

Official study title

Entia Liberty: Home Study - Evaluation of Patient Preference for a Novel Full Blood Count Home Testing Device Versus Routine Venous Monitoring

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2022
Registry last updated
Mar 13, 2024

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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