- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05025111
Entia Liberty: Capillary Validation
January 26, 2023 updated by: Entia Ltd
Entia Liberty: Clinical Performance Validation - Capillary Performance
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Manchester, United Kingdom
- The Christie NHS Foundation Trust
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Wigan, United Kingdom
- Royal Albert Edward Infirmary
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants will be recruited from the outpatients clinic at the Christie, while they are waiting for their blood tests.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To obtain/validate the value of the total error of the Entia Liberty device.
Time Frame: 3 months
|
The dataset from this study will provide evidence to support the device's performance claims.
|
3 months
|
To obtain/validate the value of the linearity of the Entia Liberty device.
Time Frame: 3 months
|
The dataset from this study will provide evidence to support the device's performance claims.
|
3 months
|
To obtain/validate the value of the bias of the Entia Liberty device.
Time Frame: 3 months
|
The dataset from this study will provide evidence to support the device's performance claims.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 12, 2022
Primary Completion (Actual)
October 26, 2022
Study Completion (Actual)
October 26, 2022
Study Registration Dates
First Submitted
August 26, 2021
First Submitted That Met QC Criteria
August 26, 2021
First Posted (Actual)
August 27, 2021
Study Record Updates
Last Update Posted (Actual)
January 27, 2023
Last Update Submitted That Met QC Criteria
January 26, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 304718
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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