NCT07287631

Brief Summary

Assess precision of the i-STAT potassium (K) and ionized calcium (iCa) tests using i-STAT CG8+ cartridge on the i-STAT 1 analyzer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
425

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Sep 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Sep 2025Dec 2026

Study Start

First participant enrolled

September 17, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 17, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

December 4, 2025

Last Update Submit

December 12, 2025

Conditions

Hematologic Tests

Keywords

Potassium (K) and ionized calcium (iCa)

Outcome Measures

Primary Outcomes (1)

  • Precision assessment

    Assess the precision of the i-STAT potassium (K) and ionized calcium (iCa) tests in mmol/L with the investigational use only (IUO) i-STAT CG8+ cartridge on the i-STAT 1 analyzer using results from capillary specimens from each subject enrolled in the study.

    Thirty (30) minutes from subject enrollment to the end of the blood draw and testing.

Study Arms (1)

Precision of potassium (K) and ionized calcium (iCa) tests in capillary blood

OTHER

Precision evaluation of the i-STAT K test and the i-STAT iCa test using i-STAT CG8+ cartridge on i-STAT 1 analyzer with capillary specimens from each subject enrolled in the study.

Diagnostic Test: Capillary blood draw

Interventions

Capillary blood drawDIAGNOSTIC_TEST

Capillary whole blood specimens collected from fingerstick(s) will be collected from each enrolled subject with blood collection capillary tubes.

Precision of potassium (K) and ionized calcium (iCa) tests in capillary blood

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)
  • ≥ 18 years of age

You may not qualify if:

  • \. Previous enrollment in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

Penn State Health Milton S. Hershey Medical Center (Hershey)

Hershey, Pennsylvania, 17033, United States

NOT YET RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

Study Officials

  • Manish Gupta, MS, MBA

    Abbott Point of Care

    STUDY DIRECTOR

Central Study Contacts

Miranda Gonzalez Aguirre, PhD

CONTACT

613-604-8539miranda.gonzalezaguirre@abbott.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

September 17, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)