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NCT06134245 Clinical Trial

HOme USability Evaluation

Cancer Clinical Trial

— HOUSE  

Official title:
HOme USability Evaluation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06134245
Other study ID # IRAS ID: 336920
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date June 30, 2024

Study information
Verified date November 2023
Source Entia Ltd
Contact Hannah Rawlinson-Smith
Phone 020 3020 0030
Email hannah.rawlinson-smith@entia.co
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To validate the usability and safety of the Liberty Analyser.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Entia Liberty
Home monitoring

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Entia Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary The Entia Liberty Analyser is safe to use Results obtained using the Entia Liberty Analyser are valid and reliable Through study completion, 1 day
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