Entia Liberty: Home Study

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Device: Entia Liberty

• Study Type: Observational
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M20 4BX
    • The Christie Nhs Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

New or existing patients on specific drug treatments recruited by their consultants

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient Group	Device: Entia Liberty; Home monitoring blood analyser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess patient preference for the Liberty self-testing pathway as compared to standard of care.	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).	12 months

Collaborators and Investigators

• Sponsor: Entia Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2023
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 317614

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No