Entia Liberty: Home Study

NCT05462288 | Completed

• 1 other identifier: 317614
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patient Group

Device: Entia Liberty

Interventions

Entia Liberty DEVICE

Home monitoring blood analyser

Patient Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Entia Ltd: lead

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 18, 2022
• Study Start: January 6, 2023
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

GB (1)