Entia Liberty: Home Study

NCT ID: NCT05462288

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-06

Study Completion Date

2023-12-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient Group

Entia Liberty

Intervention Type DEVICE

Home monitoring blood analyser

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Entia Liberty

Home monitoring blood analyser

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Entia Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

317614

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Blood Testing at Entia
NCT05580055 UNKNOWN
Capillary-Venous Paired Collection
NCT06183151 NOT_YET_RECRUITING
A Device Study in Healthy Participants
NCT04848402 COMPLETED PHASE1
Assessing Patient Preference for Infusion Systems
NCT07189013 NOT_YET_RECRUITING NA