Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol
Launched by BECKMAN COULTER, INC. · Mar 23, 2022
Trial Information
Current as of July 01, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
The purpose of this study is to gather data for the clinical development of the Sepsis Onset Warning System (SOWS) Software as Medical Device (SaMD) product to support a De Novo FDA submission and commercialization in the United States. Product development of SOWS is funded in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority.
Data will be obtained from passive prospective collection of patient encounter data throughout the duration of the planned ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • All races, ages and ethnicities
- • All patients admitted to the hospital or presenting to the Emergency Department
- Exclusion Criteria:
- • Patients not presenting to a hospital setting (e.g. urgent care, outpatient clinic excluded).
About Beckman Coulter, Inc.
Beckman Coulter, Inc. is a leading global provider of innovative diagnostic solutions and laboratory instruments, dedicated to advancing healthcare through precise and efficient testing technologies. With a strong commitment to improving patient outcomes, Beckman Coulter develops cutting-edge products for clinical laboratories, enabling healthcare professionals to make informed decisions based on accurate and timely data. The company's extensive portfolio includes hematology, chemistry, immunoassay, and molecular diagnostics, along with a robust focus on research and development to meet the evolving needs of the medical community. Through its clinical trial sponsorship, Beckman Coulter aims to foster innovation and enhance the efficacy of diagnostic tools, ultimately contributing to improved patient care worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hackensack, New Jersey, United States
Irvine, California, United States
Columbus, Ohio, United States
Cleveland, Ohio, United States
Augusta, Georgia, United States
Indianapolis, Indiana, United States
Raleigh, North Carolina, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Cincinnati, Ohio, United States
Patients applied
Trial Officials
Elliott Crouser, MD
Principal Investigator
Ohio State University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials