Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

Launched by ENTAC MEDICAL INC. · May 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new device called PrevisEA, which is designed to predict problems in the digestive system after major abdominal surgery. It works by analyzing sounds from the gastrointestinal tract to see if a patient might experience gastrointestinal impairment, a condition that can happen if the bowel doesn’t function properly after surgery. This study focuses on patients who are having elective intestinal surgeries, such as removing part of the colon or rectum.

To be eligible for this trial, you need to be between 18 and 90 years old and scheduled for specific types of intestinal surgery. Participants will use the PrevisEA device, which is a disposable and noninvasive tool that attaches to the abdomen. During the study, doctors will not use the device's results to make medical decisions, and all participants will be monitored for any complications. If you're interested in participating, it’s important to know that certain health conditions or previous surgeries might exclude you from the trial. Overall, this study aims to improve how we predict and manage digestive issues after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 and ≤ 90 years
• 2. Patient undergoing elective intestinal resection surgery including open, laparoscopic, robotic, or hand-assist technique for:
• • 1. Segmental ileocolic resection with or without diversion
• • 2. Segmental colon resection with or without diversion
• • 3. Segmental coloproctectomy with or without diversion
• • 4. Low anterior resection with or without diversion
• • 5. Abdominoperineal resection
• • 6. Total abdominal colectomy with or without diversion
• • 7. Proctocolectomy with or without end ileostomy or diversion
• • 8. Closure of end colostomy (Hartmann's reversal)
• Exclusion Criteria:
• • 1. Allergies to any of the device components (i.e., adhesive)
• • 2. Inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations(e.g., fistulas, stomas, drains, etc.)
• 3. Patients undergoing:
• • 1. Small bowel resection without colonic resection
• • 2. Transanal proctectomy without transabdominal approach
• • 3. Perineal proctosigmoidectomy
• • 4. Closure of loop colostomy or ileostomy
• • 4. Patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection