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A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment
Recruiting
This device listens to and records abdominal sounds, which provides data that can help predict gastrointestinal impairment (GII). GII is a condition that is defined as the failure of oral re-feeding after abdominal surgery. This happens when any of the following events happen beyond 24-hours after abdominal surgery; vomiting, need to reverse the diet, or need to place a nasogastric (NG) tube.
Male or Female
18 years and over
Inclusion Criteria:
• 18 to 90 years of age
• having an elective intestinal resection surgery (specific types, study staff will review)
Exclusion Criteria:
• allergy to skin adhesive
• unable to have device applied to the skin on the abdomen
• evidence of infection before surgery, including a deep wound infection or urinary tract infection
• specific types of surgery (study staff will review)
Device: PrevisEA device
Digestive & Liver Health
Clinics and Surgery Center (CSC), Bowel surgery
Addie Westman - westm128@umn.edu
Wolfgang Gaertner, MD
NA
STUDY00012967
See this study on ClinicalTrials.gov