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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.

I'm interested

Male or Female
18 years and over
This study is NOT accepting healthy volunteers
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
N/A
STUDY00012967
See this study on ClinicalTrials.gov

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