Status:
RECRUITING
Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment
Lead Sponsor:
Entac Medical Inc.
Conditions:
Gastrointestinal Complication
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
PrevisEA is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal impairment (GII). GII is most commonly assoc...
Eligibility Criteria
Inclusion
- Age ≥ 18 and ≤ 90 years
- Patient undergoing elective intestinal resection surgery including open, laparoscopic, robotic, or hand-assist technique for:
- Segmental ileocolic resection with or without diversion
- Segmental colon resection with or without diversion
- Segmental coloproctectomy with or without diversion
- Low anterior resection with or without diversion
- Abdominoperineal resection
- Total abdominal colectomy with or without diversion
- Proctocolectomy with or without end ileostomy or diversion
- Closure of end colostomy (Hartmann's reversal)
Exclusion
- Allergies to any of the device components (i.e., adhesive)
- Inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations(e.g., fistulas, stomas, drains, etc.)
- Patients undergoing:
- Small bowel resection without colonic resection
- Transanal proctectomy without transabdominal approach
- Perineal proctosigmoidectomy
- Closure of loop colostomy or ileostomy
- Patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection
Key Trial Info
Start Date :
September 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04880473
Start Date
September 14 2021
End Date
December 1 2024
Last Update
March 13 2024
Active Locations (8)
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1
Adventist Health System/Sunbelt, Inc. d/b/a AdventHealth Orlando
Orlando, Florida, United States, 32803
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Spectrum Health Blodgett Hospital
Grand Rapids, Michigan, United States, 49503
4
University of Minnesota
Minneapolis, Minnesota, United States, 55414