NCT07345091

Feasibility Performance Study of ABL90 FLEX PLUS HEM

Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 95 (estimated)
• Sponsor: Radiometer Medical ApS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This feasibility performance study evaluates the ABL90 FLEX PLUS HEM device for its analytical performance in a clinical setting. The study aims to evaluate the performance of the hemolysis detection feature.

Detailed description

The study is designed to assess the feasibility and performance of the ABL90 FLEX PLUS HEM device in a clinical environment. It will involve testing whole blood samples using the device and comparing results against established reference method. The primary focus is on validating the device's performance of the hemolysis detection function. The study will be conducted at one selected clinical site with trained personnel and will follow a predefined protocol to ensure consistency and reliability of data collection. The outcomes will inform future clinical studies aimed at supporting regulatory submissions and clinical adoption.

Conditions

• Hemolysis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	The purpose of this study is to investigate the performance of the hemolysis detection function on the ABL90 FLEX PLUS HEM using arterial or venous whole blood	The hemolysis detection function is a newly developed sample quality feature on the ABL90 FLEX PLUS HEM intended to detect hemolyzed samples and to improve the reliability of the results provided by blood gas analyzer.

Timeline

• Start date: 2025-08-04
• Primary completion: 2026-05-10
• Completion: 2026-06-10
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study