NCT04933760

CV-SQuISH-ED: Clinical Validation Study

CV-SQuISH-ED: A Clinical Validation Solving the Question of Inflammation or Sepsis Hastily in the Emergency Department

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 599 (actual)
• Sponsor: Cytovale, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the diagnostic performance of the investigational Cytovale System \& IntelliSep Test as a diagnostic marker of sepsis in a population of patients presenting to the emergency department with signs or suspicion of infection compared to retrospective physician adjudication, per the sepsis 3 definition, of those patients.

Detailed description

This is a multi-site prospective study to evaluate the diagnostic performance of the investigational Cytovale System \& IntelliSep Test for patients presenting to the Emergency Department with signs or suspicion of infection. The IntelliSep Test is a microfluidic test that measures the biophysical properties of human leukocytes in conjunction with other laboratory findings and clinical assessments to aid in the early detection of sepsis with organ dysfunction occurring within the first three days after the blood sample collection.

Conditions

• Sepsis
• Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cytovale IntellipSep test	The Cytovale IntelliSep test measures a series of physical properties that indicate activation of leukocytes obtained from a venous K2-EDTA anti-coagulated whole blood sample.

Timeline

• Start date: 2021-05-18
• Primary completion: 2022-01-13
• Completion: 2022-05-01
• First posted: 2021-06-22
• Last updated: 2022-03-31

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study