Entia Liberty: Home Study | NCT05462288

Studies
Entia Liberty: Home Study

NCT05462288

Sponsor

Entia Ltd

Status

Completed

Last Update Posted

Mar 13, 2024Actual

Enrollment

22Actual

Phase

Not provided

Conditions

Cancer

Interventions

Entia Liberty

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 6, 2023Actual

Primary Completion Date

Dec 5, 2023Actual

Completion Date

Dec 5, 2023Actual

First Submitted Date

Jun 20, 2022

First Submission Date that Met QC Criteria

Jul 13, 2022

First Posted Date

Jul 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2024

Last Update Posted Date

Mar 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Label	Type	Description	Intervention Names
Patient Group			Device: Entia Liberty

Name	Type	Description	Arm Group Labels	Other Names
Entia Liberty	Device	Home monitoring blood analyser	Patient Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample