Entia Liberty: Usability Validation

Completed

• Conditions: Cancer

• Registration Number: NCT05027256
• Lead Sponsor: Entia Ltd

Brief Summary

This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's validation of the device. Participants will be trained to take an Entia Liberty test in a simulated home environment and a trained healthcare professional will perform another test from the same participant (different finger) on a separate device. The results will be compared. Usability data will be observed and the participants will complete a questionnaire after the tests have been performed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-08-30
• Study Start: 2022-09-12
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age >18 years old at the time of study entry
• Can provide written informed consent
• Patients who are currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and have received at least one cycle
• Sufficient hearing to be able to participate in a video training session

Exclusion Criteria

• Known inherited or acquired bleeding disorder
• History of haematological malignancy
• Known poorly controlled anti-coagulation
• Inadequate use and understanding of the English language, requiring a translator
• Participant unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
• Previously taken part in the 'PERTH-2' study involving a prototype device

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants able to use the Entia Liberty device as specified in the validation procedure is 80%.	3 months	At least 24 of the participants are able to complete the Entia Liberty test.
Number of participants with new severe usability problems identified.	3 months	Identification of the number of participants that were deviating away from the instructions for use, resulting in increased risk to the results or themselves
Number of participants with study-related adverse events as assessed by the Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)	3 months	Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)

Trial Locations

Locations (2)

Buckinghamshire Healthcare NHS Trust; 🇬🇧 Aylesbury, United Kingdom

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom