Device to predict gastrointestinal impairment after surgery
A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment
This study is testing a new device that listens to sounds from the stomach and intestines to see if it can help predict problems after major abdominal surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Entac Medical Inc. Industry-sponsored |
| Locations | 8 sites (Orlando, Florida and 7 other locations) |
| Trial ID | NCT04880473 on ClinicalTrials.gov |
What this trial studies
The PrevisEA device is a noninvasive, disposable tool that analyzes sounds from the gastrointestinal tract to predict gastrointestinal impairment, particularly after major abdominal surgeries. This impairment can lead to complications such as postoperative ileus or bowel obstruction, which affect a patient's ability to resume oral feeding. The device operates without informing medical decisions during the study, and researchers will remain blinded to its results. The study aims to evaluate the effectiveness of this device in a controlled surgical setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 undergoing elective intestinal resection surgeries.
Not a fit: Patients with allergies to device components or those undergoing specific types of surgeries not included in the study may not benefit.
Why it matters
Potential benefit: If successful, this device could help predict gastrointestinal complications early, potentially improving patient outcomes and recovery times after surgery.
How similar studies have performed: While the approach of using audio spectral analysis is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orlando, Florida and 7 other locations
- Adventist Health System/Sunbelt, Inc. d/b/a AdventHealth Orlando — Orlando, Florida, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Spectrum Health Blodgett Hospital — Grand Rapids, Michigan, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Entac Medical Inc.
- Email: previsea-001@clinicalresearchstrategies.com
- Phone: 845-773-8473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.