HOUSE: HOme USability Evaluation

• Sponsor: Entia Ltd (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06134245
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 4

Study Details

Study Description

Brief Summary

To validate the usability and safety of the Liberty Analyser.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Device: Entia Liberty

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: HOme USability Evaluation
• Anticipated Study Start Date: Mar 1, 2024
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Outcome Measures

Primary Outcome Measures

1. The Entia Liberty Analyser is easy to use [Through study completion, 1 day]

   Users can easily carry out a test using the Entia Liberty Analyser

2. The Entia Liberty Analyser is safe to use [Through study completion, 1 day]

   Results obtained using the Entia Liberty Analyser are valid and reliable

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Entia Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Entia Ltd
• ClinicalTrials.gov Identifier: NCT06134245
• Other Study ID Numbers: IRAS ID: 336920
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 18, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 18, 2023