Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

NARecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

September 14, 2021

Primary Completion Date

September 1, 2024

Study Completion Date

December 1, 2024

Conditions
Gastrointestinal Complication
Interventions
DEVICE

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.

Trial Locations (8)

32803

RECRUITING

Adventist Health System/Sunbelt, Inc. d/b/a AdventHealth Orlando, Orlando

44195

RECRUITING

The Cleveland Clinic Foundation, Cleveland

49503

RECRUITING

Spectrum Health Blodgett Hospital, Grand Rapids

55414

RECRUITING

University of Minnesota, Minneapolis

55905

RECRUITING

Mayo Clinic, Rochester

60611

RECRUITING

Northwestern University, Chicago

97239

RECRUITING

Oregon Health and Science University, Portland

27599-1350

RECRUITING

The University of North Carolina at Chapel Hill, Chapel Hill

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Entac Medical Inc.

INDUSTRY

NCT04880473 - Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment | Biotech Hunter | Biotech Hunter