HOme USability Evaluation (HOUSE)

November 10, 2023 updated by: Entia Ltd
To validate the usability and safety of the Liberty Analyser.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Entia Liberty Analyser is easy to use
Time Frame: Through study completion, 1 day
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
Time Frame: Through study completion, 1 day
Results obtained using the Entia Liberty Analyser are valid and reliable
Through study completion, 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Entia Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRAS ID: 336920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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