Entia Liberty: Home Study

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05462288
• Other study ID #: 317614
• Status: Completed
• Start date: January 6, 2023
• Est. completion date: December 5, 2023

Study information

• Verified date: March 2024
• Source: Entia Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 5, 2023
• Est. primary completion date: December 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• Entia Liberty
Home monitoring blood analyser

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Entia Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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