HealthyNCT05580055
Blood Testing at Entia
An observational study of Healthy and Blood Cell Count, run by Entia Ltd at 1 site in United Kingdom.
Trial summary
The investigators are recruiting healthy volunteers to donate 1-5 (depending on study visits. and donors will be notified upon invitation) finger prick blood samples or venous samples to Entia for the further development and testing of our blood analyser. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Blood Cell Count
- What is being tested?
- Affinity
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Oct 2021to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers, enrolled by invitation only
Who may be able to join
- Aged ≥ 21 years Apparently healthy Able to provide written informed consent Registered with a general practitioner (GP)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Blood Donation of Healthy Blood for Prototype Testing at Entia
The investigators are recruiting healthy volunteers to donate 1-5 (depending on study visits. and donors will be notified upon invitation) finger prick blood samples or venous samples to Entia for the further development and testing of our blood analyser. The venous samples are taken by a registered nurse hired via a third party company. The results of the blood tests are not informed to the participants unless they explicitly ask for it.
- Conditions
- Healthy, Blood Cell Count
- Being tested
- Affinity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AffinityDiagnostic test
Blood Analyser
| Study group | Role | What they receive |
|---|---|---|
| Capillary Sample | This group donates finger prick blood samples to Entia for the purpose of development. Receives: Diagnostic Test: Affinity | |
| Venous Sample | This group donates venous blood samples to Enta, taken by a registered nurse. Receives: Diagnostic Test: Affinity |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in counts of the device tested blood vs the gold standard tested blood.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start22 Oct 2021
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Entia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580055
- Sponsor's protocol ID
- 298186
- Status last verified
- Aug 2026
- First submitted
- 11 Oct 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: iterative development data only
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Donation of Healthy Blood for Prototype Testing at Entia
- ClinicalTrials.gov ID
- NCT05580055
- Acronym / sponsor ID
- 298186
- Conditions
- Healthy, Blood Cell Count
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Entia LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are recruiting healthy volunteers to donate 1-5 (depending on study visits. and donors will be notified upon invitation) finger prick blood samples or venous samples to Entia for the further development and testing of our blood analyser. The venous samples are taken by a registered nurse hired via a third party company. The results of the blood tests are not informed to the participants unless they explicitly ask for it.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capillary Sample | – | Diagnostic Test: AffinityThis group donates finger prick blood samples to Entia for the purpose of development. |
| Venous Sample | – | Diagnostic Test: AffinityThis group donates venous blood samples to Enta, taken by a registered nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers, enrolled by invitation only
Key inclusion criteria (1 listed)
- Aged ≥ 21 years Apparently healthy Able to provide written informed consent Registered with a general practitioner (GP)
Key exclusion criteria (4 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AffinityBlood Analyser | Diagnostic test | Capillary Sample, Venous Sample |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No. iterative development data only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Blood Cell Count, run by Entia Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in counts of the device tested blood vs the gold standard tested blood. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.