Precision of Potassium (K) Test in Capillary Whole BloodNCT06291493
Precision Study Measuring Potassium (K) in Capillary Specimens
A study testing Fingerstick blood draw in people with Precision of Potassium (K) Test in Capillary Whole Blood, run by Abbott Point of Care at 4 sites in 2 countries.
Trial summary
Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Precision of Potassium (K) Test in Capillary Whole Blood
- What is being tested?
- Fingerstick blood draw
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 7 May 2024to 13 Sep 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed and dated consent form (if required by the IRB)
- ≥ 18 years of age
Who cannot join
- Prior enrollment in the study
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Maryland, Baltimore (UMD)
Baltimore, Maryland, 21201
Penn State Health Milton S. Hershey Medical Center (Hershey)
Hershey, Pennsylvania, 17033
Eastside Research Associates (ERA)
Redmond, Washington, 98052
About this study
Official title: Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer
Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer.
Read the detailed description
The objective of this study is to assess the precision of the i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer with investigational software using results from two (2) different fingerstick specimens from the same subject across the K measurement range.
- Being tested
- Fingerstick blood draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingerstick blood drawDiagnostic test
Also called Blood draw
Capillary blood specimen collected from two separate fingerstick blood draws.
| Study group | Role | What they receive |
|---|---|---|
| Precision assessment of Potassium (K) test in capillary blood sample | Other | Prospectively collected capillary specimens from two separate fingerstick blood draws. Receives: Diagnostic Test: Fingerstick blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision for Potassium (K) Test
Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens using the i-STAT CG8+ Cartridge with the i-STAT 1 Analyzer
Measured: Up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start7 May 2024
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precision of Potassium (K) Test in Capillary Whole BloodStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Capillary precision analysis will be performed for Potassium K.
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Point of Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manish Gupta, BS, MBA, Study director, Abbott Point of Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291493
- Sponsor's protocol ID
- CS-2024-0002
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer
- ClinicalTrials.gov ID
- NCT06291493
- Acronym / sponsor ID
- CS-2024-0002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Abbott Point of CareIndustry (pharma, biotech, devices)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 4 Mar 2024 (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.
Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer.
Detailed description
The objective of this study is to assess the precision of the i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer with investigational software using results from two (2) different fingerstick specimens from the same subject across the K measurement range.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Capillary precision analysis will be performed for Potassium K.
| Arm | Type | Receives |
|---|---|---|
| Precision assessment of Potassium (K) test in capillary blood sample | Other | Diagnostic Test: Fingerstick blood drawProspectively collected capillary specimens from two separate fingerstick blood draws. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed and dated consent form (if required by the IRB)
- ≥ 18 years of age
Key exclusion criteria (1 listed)
- Prior enrollment in the study
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 |
|---|---|---|
| Fingerstick blood drawAlso: Blood drawCapillary blood specimen collected from two separate fingerstick blood draws. | Diagnostic test | Precision assessment of Potassium (K) test in capillary blood sample |
Primary outcome
Precision for Potassium (K) Test
Time frame: Up to 5 minutes
Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens using the i-STAT CG8+ Cartridge with the i-STAT 1 Analyzer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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.
Manish Gupta, BS, MBA study director
Abbott Point of Care
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fingerstick blood draw in people with Precision of Potassium (K) Test in Capillary Whole Blood, run by Abbott Point of Care at 4 sites in 2 countries.
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 1 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: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Precision for Potassium (K) Test (time frame: Up to 5 minutes). 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 19 Mar 2025.