Healthy VolunteersREFINENCT07031882
Liberty Analyzer WBC System: Reference Interval Study
An observational study of Healthy Volunteers, run by Entia Ltd at 1 site in United States.
Trial summary
The purpose of this study is to establish the reference intervals for WBC and granulocytes for the Liberty Analyzer WBC System. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Liberty Analyzer WBC System
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Non-diseased adults.
Who may be able to join
- Aged ≥21 years old at the time of study entry
- Able to provide written informed consent
Who cannot join
- Inadequate use and understanding of the English language, requiring a translator
- Undergone tattooing or body piercing within the 7 days prior to the study visit
- Undergone vaccination within the 7 days prior to the study visit
- Episode of upper respiratory infection within the 30 days prior to the study visit
- Use of oral corticosteroid medications within the 30 days prior to the study visit
- Undergone surgery within the 90 days prior to the study visit
Show all 40Show fewer
- Been hospitalised within the 90 days prior to the study visit
- Donated blood or plasma 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
- Current diagnosis of anemia (including iron deficiency anemia, vitamin deficiency anemia, aplastic anemia and/or hemolytic anemia)
- Current diagnosis of high blood pressure
- Current diagnosis of diabetes mellitus
- History or current diagnosis of chronic kidney disease or end-stage renal disease
- History or current diagnosis of cancer
- History or current diagnosis of cardiovascular disease
- History or current use of radiotherapy of the chest or abdomen
- History or current diagnosis of the following conditions known to affect the CBC differential count:
- Immune Thrombocytopenic Purpura (ITP)
- Systemic Lupus Erythematosus (SLE)
- Rheumatoid Arthritis (RA)
- Antiphospholipid Syndrome (APS)
- Sjogren's Syndrome
- Tuberculosis (TB)
- HIV
- Hepatitis B/C
- G6PD Deficiency
- Sickle Cell Disease/Trait
- Inflammatory Bowel Disease (IBD)
- Eptein Barr virus
- CMV Cytomegalovirus
- Myelodysplastic Syndromes (MDS) / CMML
- Asplenia
- Participants who meet the following criteria will be excluded a posteriori:
- Hemoglobin, hematocrit, red cell and/or total white blood cell count obtained by standard laboratory analysis of the participant's venous blood sample, that fall(s) outside of the applicable reference interval(s) in use at the study site.
- Iron, ferritin, transferrin, total Iron Binding Capacity (TIBC) and/or transferrin saturation results obtained by standard laboratory analysis of the participant's venous blood sample, that fall(s) outside of the applicable reference interval(s) in use at the study site.
- Alanine aminotransferase (ALT), aspartate aminotransferase ( AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), total bilirubin, conjugated bilirubin, albumin and/or total protein results obtained by standard laboratory analysis of the participant's venous blood sample, that fall(s) outside of the applicable reference interval(s) in use at the study site.
- Creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), sodium, potassium, chloride and/or bicarbonate results obtained by standard laboratory analysis of the participant's venous blood sample, that fall(s) outside of the applicable reference interval(s) in use at the study site.
- C-reactive protein (CRP) results obtained by standard laboratory analysis of the participant's venous blood sample, that fall outside of the applicable reference interval in use at the study site.
- Self-report to be taking medication(s) that are subsequently identified as interfering substances for the Liberty Analyzer WBC System
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise & Sport Nutrition Laboratory
College Station, Texas, 77843
About this study
The purpose of this study is to establish the reference intervals for WBC and granulocytes for the Liberty Analyzer WBC System.
- Conditions
- Healthy Volunteers
- Being tested
- Liberty Analyzer WBC System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberty Analyzer WBC SystemDevice
Participants will donate capillary samples to be analysed by the Liberty Analyzer System WBC
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described Receives: Device: Liberty Analyzer WBC System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the 95% reference interval for WBC for the Liberty Analyzer WBC System, reported with 90% confidence intervals.
Measured: Through study completion, an average of 1 day
To establish the 95% reference interval for absolute granulocytes for the Liberty Analyzer WBC System, reported with 90% confidence intervals.
Measured: Through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start19 Mar 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Why it stopped: For interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 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
- NCT07031882
- Sponsor's protocol ID
- CTM-PRO-00174
- Acronym
- REFINE
- Status last verified
- Jun 2026
- First submitted
- 29 May 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined by study management group.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberty Analyzer WBC System: Reference Interval Study
- ClinicalTrials.gov ID
- NCT07031882
- Acronym / sponsor ID
- REFINE / CTM-PRO-00174
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: For interim analysis.
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Entia LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Jun 2025 (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 purpose of this study is to establish the reference intervals for WBC and granulocytes for the Liberty Analyzer WBC System.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Liberty Analyzer WBC System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Non-diseased adults.
Key inclusion criteria (2 listed)
- Aged ≥21 years old at the time of study entry
- Able to provide written informed consent
Key exclusion criteria (40 listed)
- Inadequate use and understanding of the English language, requiring a translator
- Undergone tattooing or body piercing within the 7 days prior to the study visit
- Undergone vaccination within the 7 days prior to the study visit
- Episode of upper respiratory infection within the 30 days prior to the study visit
- Use of oral corticosteroid medications within the 30 days prior to the study visit
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 |
|---|---|---|
| Liberty Analyzer WBC SystemParticipants will donate capillary samples to be analysed by the Liberty Analyzer System WBC | Device | Healthy volunteers |
Primary outcome
To establish the 95% reference interval for WBC for the Liberty Analyzer WBC System, reported with 90% confidence intervals.
Time frame: Through study completion, an average of 1 day
To establish the 95% reference interval for absolute granulocytes for the Liberty Analyzer WBC System, reported with 90% confidence intervals.
Time frame: Through study completion, an average of 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Undecided. To be determined by study management group.
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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. This study is not recruiting at the moment.
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 Volunteers, run by Entia Ltd at 1 site in United States.
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 2 inclusion and 40 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: paused, as of the sponsor's last update on 7 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 States. 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?
Results are not available in the source record.
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?
To establish the 95% reference interval for WBC for the Liberty Analyzer WBC System, reported with 90% confidence intervals. (time frame: Through study completion, an average of 1 day). The study lists 2 primary outcomes in all. 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 7 Aug 2026.