HOme USability Evaluation | NCT06134245

Studies
HOme USability Evaluation

NCT06134245

Sponsor

Entia Ltd

Status

Unknown status

Last Update Posted

Nov 18, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Cancer

Interventions

Entia Liberty

Countries

Not provided

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Estimated

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Nov 8, 2023

First Submission Date that Met QC Criteria

Nov 10, 2023

First Posted Date

Nov 18, 2023Actual

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

Nov 10, 2023

Last Update Posted Date

Nov 18, 2023Actual

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

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

100Estimated

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Entia Liberty Analyser is easy to use	Users can easily carry out a test using the Entia Liberty Analyser	Through study completion, 1 day
The Entia Liberty Analyser is safe to use	Results obtained using the Entia Liberty Analyser are valid and reliable	Through study completion, 1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergoing systemic anti-cancer therapy (SACT)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 at enrolment
Adequate English language skills (not requiring a translator) to participate in participant training and use the Entia Liberty analyser
Patients capable of providing written informed consent

Exclusion Criteria:

History or current diagnosis of haematological malignancy
Patients with eyesight or hearing limitations or other disabilities that preclude the use of the Entia Liberty analyser or participation in training
Inadequate use and understanding of the English language, requiring a translator

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

Adults with a diagnosis of solid tumour cancer, who are currently undergoing systemic anti-cancer therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hannah Rawlinson-Smith	Contact	020 3020 0030		hannah.rawlinson-smith@entia.co
Madeline Lok	Contact	020 3020 0030		madeline.lok@entia.co

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided