NCT06295835

Brief Summary

Method comparison study for Potassium (K) and ionized calcium (iCa).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 26, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 31, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

February 26, 2024

Last Update Submit

March 17, 2025

Conditions

Potassium (K) & Ionized Calcium (iCa) in Capillary Whole Blood

Outcome Measures

Primary Outcomes (2)

  • Performance comparison

    Compare the performance of the Potassium (K) test using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K test on a comparator device.

    Up to 5 minutes

  • Performance comparison

    Compare the performance of the ionized calcium (iCa) test using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the iCa test on a comparator device.

    Up to 5 minutes

Study Arms (1)

Method comparison for K and iCa Tests using capillary whole blood specimens.

OTHER

Compare the performance of the K and iCa Tests using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K and iCa Tests on the comparator device using capillary whole blood specimens collected from two separate fingersticks.

Diagnostic Test: Fingerstick blood draw

Interventions

Fingerstick blood drawDIAGNOSTIC_TEST

Capillary blood specimen collected from two separate fingersticks.

Method comparison for K and iCa Tests using capillary whole blood specimens.

Eligibility Criteria

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

You may qualify if:

  • Signed and dated consent form (if required by the IRB)
  • ≥ 18 years of age

You may not qualify if:

  • Prior enrollment in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Maryland (UMD)

Baltimore, Maryland, 17033, United States

Location

Penn State University Hershey Medical Center (Hershey)

Hershey, Pennsylvania, 17033, United States

Location

Eastside Research Associates (ERA)

Redmond, Washington, 98052, United States

Location

Abbott Point of Care (APOC)

Ottawa, Ontario, K2H 8V4, Canada

Location

Study Officials

  • Manish Gupta, BS, MBA

    Abbott Point of Care

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Capillary whole blood specimens will be tested in duplicate on the i-STAT 1 Analyzer with the CG8+ cartridge and a blood analyte testing comparator device.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 6, 2024

Study Start

May 31, 2024

Primary Completion

January 29, 2025

Study Completion

January 29, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(3)