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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05027256
Other study ID # 304701
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 12, 2022
Est. completion date November 30, 2022

Study information

Verified date January 2023
Source Entia Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 30, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Entia Liberty
Home Monitoring solution

Locations

Country Name City State
United Kingdom Buckinghamshire Healthcare NHS Trust Aylesbury
United Kingdom The Christie NHS Foundation Trust Manchester

Sponsors (1)

Lead Sponsor Collaborator
Entia Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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