Cancer Clinical Trial
Official title:
Entia Liberty: Clinical Performance Validation - Capillary Performance
| NCT number | NCT05025111 |
| Other study ID # | 304718 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 12, 2022 |
| Est. completion date | October 26, 2022 |
| Verified date | January 2023 |
| Source | Entia Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | October 26, 2022 |
| Est. primary completion date | October 26, 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 - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | The Christie NHS Foundation Trust | Manchester | |
| United Kingdom | Royal Albert Edward Infirmary | Wigan |
| Lead Sponsor | Collaborator |
|---|---|
| Entia Ltd | The Christie NHS Foundation Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To obtain/validate the value of the total error of the Entia Liberty device. | The dataset from this study will provide evidence to support the device's performance claims. | 3 months | |
| Primary | To obtain/validate the value of the linearity of the Entia Liberty device. | The dataset from this study will provide evidence to support the device's performance claims. | 3 months | |
| Primary | To obtain/validate the value of the bias of the Entia Liberty device. | The dataset from this study will provide evidence to support the device's performance claims. | 3 months |
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