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CV-SQuISH-ED: Clinical Validation Study

NCT04933760 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 599

Last updated 2022-03-31

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Cytovale, Inc.

    lead INDUSTRY

Principal Investigators

  • Tonya Jagneaux, MD · Lady of the Lake Regional Medical Center

  • Hariharan Regunath, MD · University of Missouri-Columbia

  • Liza Rosenman, MD · University of Washington

  • Simon Mahler, MD · Wake Forest University Health Sciences

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2022-01-13
Completion
2022-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04933760 on ClinicalTrials.gov