Trials / Active Not Recruiting
Active Not RecruitingNCT07382076
Clinical Evaluation of the i-STAT ACTpro Cartridge in an Adult Population
Clinical Evaluation of the i-STAT ACTpro Cartridge Using Venous and Arterial Whole Blood Specimens on the i-STAT 1 Analyzer in an Adult Population
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (actual)
- Sponsor
- Abbott Point of Care · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Measuring Activated Clotting Time (ACT) using the i-STAT ACTpro cartridge on the i-STAT 1 analyzer compared to a comparator device.
Detailed description
The purpose of this study is to conduct a clinical evaluation of the investigational i-STAT ACTpro cartridge on the i-STAT 1 analyzer compared to a comparator device for measuring Activated Clotting Time (ACT) on venous and arterial whole blood specimens from adult participants. The study will be conducted using whole blood specimens from participants undergoing Dialysis, Extracorporeal Life Support (ECLS)/ Extracorporeal Membrane Oxygenation (ECMO), and procedures in Electrophysiology Laboratories (EP Labs), Cardiac Catheterization Laboratories (Cath Labs), Interventional Radiology (IR) Units, and Cardiovascular Operating Rooms (CVOR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Blood draw | A total volume of no more than 5mL of blood will be prospectively collected from subjects. |
Timeline
- Start date
- 2023-12-15
- Primary completion
- 2026-03-30
- Completion
- 2026-03-30
- First posted
- 2026-02-02
- Last updated
- 2026-02-02
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07382076. Inclusion in this directory is not an endorsement.