Entia Liberty: Usability Validation

NCT05027256 | Completed

• 1 other identifier: 304701
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

• Number of participants able to use the Entia Liberty device as specified in the validation procedure is 80%.

  At least 24 of the participants are able to complete the Entia Liberty test.

  3 months

• Number of participants with new severe usability problems identified.

  Identification of the number of participants that were deviating away from the instructions for use, resulting in increased risk to the results or themselves

  3 months

• 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)

  Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)

  3 months

Interventions

Entia Liberty DEVICE

Home Monitoring solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants recruited from the outpatients clinic at the Christie

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Entia Ltd: lead

Study Sites (2)

Buckinghamshire Healthcare NHS Trust

Aylesbury, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: August 30, 2021
• Study Start: September 12, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

GB (2)