400
Participants
Start Date
September 14, 2021
Primary Completion Date
September 1, 2024
Study Completion Date
December 1, 2024
PrevisEA device
The PrevisEA device is placed and activated on the patient's abdomen immediately post-op (within 1 hour of the completion of surgery) and maintained in position for at least 12 hours, counting the number of times MH4 is detected within a four-minute period at hourly intervals. The device determines the MH4 biomarker counts at each hourly collection point and the data are stored on the device. Under normal conditions, transformations of the data are visualized on the display. For this clinical trial, the display is obscured. Therefore, no value will be displayed for interpretation since this is a non-intervention trial and the device is not intended to affect or influence the standard of care for study participants.
RECRUITING
Adventist Health System/Sunbelt, Inc. d/b/a AdventHealth Orlando, Orlando
RECRUITING
The Cleveland Clinic Foundation, Cleveland
RECRUITING
Spectrum Health Blodgett Hospital, Grand Rapids
RECRUITING
University of Minnesota, Minneapolis
RECRUITING
Mayo Clinic, Rochester
RECRUITING
Northwestern University, Chicago
RECRUITING
Oregon Health and Science University, Portland
RECRUITING
The University of North Carolina at Chapel Hill, Chapel Hill
Lead Sponsor
Entac Medical Inc.
INDUSTRY