Entia Liberty: Home Study

Completed

• Conditions: Cancer
• Interventions: Device: Entia Liberty

• Registration Number: NCT05462288
• Lead Sponsor: Entia Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-18
• Study Start: 2023-01-06
• Primary Completion: 2023-12-05
• Study Completion: 2023-12-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient Group	Entia Liberty	-

Primary Outcome Measures

Name	Time	Method
To assess patient preference for the Liberty self-testing pathway as compared to standard of care.	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).

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom