Precision Study Measuring Potassium (K) in Capillary Specimens

March 20, 2024 updated by: Abbott Point of Care

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Prior enrollment in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Precision assessment of Potassium (K) test in capillary blood sample
Prospectively collected capillary specimens from two separate fingerstick blood draws.
Diagnostic test: Fingerstick blood draw
Capillary blood specimen collected from two separate fingerstick blood draws.
Other Names:
  • Blood draw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Point of Care

Investigators

  • Study Director: Manish Gupta, BS, MBA, Abbott Point of Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CS-2024-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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