Entia Liberty: Capillary Validation

NCT ID: NCT05025111

Last Updated: 2023-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-12

Study Completion Date

2022-10-26

Brief Summary

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This study is a clinical performance validation study to evaluate the performance of the Entia Liberty device. Patients undergoing routine venepuncture blood tests will be recruited to have an Entia Liberty test (by finger-prick) done on them by a trained healthcare professional. The results from that finger-prick test will be compared against the results from the routine venepuncture blood test (reference method) and subsequently, excess blood from the routine venepuncture test will be run on another Entia Liberty device in the laboratory. All three results (Entia Liberty capillary, Entia Liberty venous and gold standard venous) will be compared against each other to prove Entia Liberty's performance claims.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Entia Liberty

Home monitoring device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years old at the time of study entry
* Currently receiving standard of care systemic anti- cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle.
* Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
* Can provide written informed consent
* Blood samples collected and stored in K2-EDTA vacutainers only

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Christie NHS Foundation Trust

OTHER

Sponsor Role collaborator

Entia Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Royal Albert Edward Infirmary

Wigan, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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304718

Identifier Type: -

Identifier Source: org_study_id

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