Blood Testing at Entia
Blood Donation of Healthy Blood for Prototype Testing at Entia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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London
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London, London, United Kingdom, WC1X 8LU
- Entia Ltd
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Aged ≥ 21 years Apparently healthy Able to provide written informed consent Registered with a general practitioner (GP)
Exclusion Criteria:
Inadequate understanding of the English language (written and verbal) that would require a translator Been hospitalised within 90 days prior to their study visit Donated whole blood or plasma to a blood bank within the 90 days prior to the study visit Pregnant at the time of the study visit Breastfeeding at the time of the study visit History of vasovagal syncope following blood draw
History or current diagnosis of the following conditions:
Cancer Cardiovascular disease Chronic kidney disease or end-stage renal disease Bleeding disorder (including but not limited to Immune Thrombocytopenia (ITP), hemophilia, von Willebrand disease (VWD)) Blood clotting disorder (including but not limited to thrombophilia, antiphospholipid syndrome) G6PD deficiency Inflammatory bowel disease Myelodysplastic syndrome Ebola Tuberculosis HIV Hepatitis B or C Current diagnosis of Epstein-Barr Virus or Cytomegalovirus Current diagnosis of diabetes mellitus, unless controlled by diet alone OR participant has been taking the same dose of the same medication for 4 weeks or more and are feeling fit and well.
Undergone organ transplantation Anemia, unless the participant is feeling fit and well (no dizziness, fatigue, shortness of breath etc)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Capillary Sample
This group donates finger prick blood samples to Entia for the purpose of development.
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Blood Analyser
|
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Venous Sample
This group donates venous blood samples to Enta, taken by a registered nurse.
|
Blood Analyser
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The difference in counts of the device tested blood vs the gold standard tested blood.
Time Frame: Day 1
|
Venous blood drawn will be tested on a laboratory analyser, in which the results will be compared against the results of blood samples (whether capillary or venous) when tested on Entia's analyser.
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 298186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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