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Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment
NCT04880473 · View on ClinicalTrials.gov ↗
Study 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 associated with postoperative ileus (POI), but could be the result of other causes, such as early postoperative bowel obstruction. GII is defined as failure of successful early oral re-feeding in a subject undergoing major abdominal surgery. For subjects who are allowed to resume a diet during the first 24 hours after surgery, a failure to successfully orally re-feed a subject is defined as presentation with emesis, requiring a reversal of diet, or the placement of a nasogastric tube on first postoperative day or later. The device is considered non-significant risk (NSR). The device does not inform medical decisions in this study. Researchers will be blinded to results of the device during this study.
Conditions Studied
Interventions
- DEVICE PrevisEA device
Study Locations (8)
Minnesota
- University of Minnesota — Minneapolis
- Mayo Clinic — Rochester
Florida
- Adventist Health System/Sunbelt, Inc. d/b/a AdventHealth Orlando — Orlando
Illinois
- Northwestern University — Chicago
Michigan
- Spectrum Health Blodgett Hospital — Grand Rapids
North Carolina
- The University of North Carolina at Chapel Hill — Chapel Hill
Ohio
- The Cleveland Clinic Foundation — Cleveland
Oregon
- Oregon Health and Science University — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2021-09-14 |
| Est. Completion | 2024-12-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04880473
The ClinicalTrials.gov registry entry for NCT04880473 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Entac Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Gastrointestinal Complication appearing as the primary indexed condition, and to 1 intervention — of which PrevisEA device is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04880473 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Minnesota, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04880473 about?
NCT04880473 is a clinical study titled "Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment". 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 associated with postoperative ileus (POI), but could be the result of other causes, such as early postope...
What is the current status of trial NCT04880473?
This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2021-09-14. Estimated completion is 2024-12-01.
What conditions does trial NCT04880473 study?
This clinical trial studies the following conditions: Gastrointestinal Complication. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04880473?
The interventions under investigation include: PrevisEA device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04880473?
This trial is sponsored by Entac Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04880473 being conducted?
This trial has 8 study locations across Florida, Illinois, Michigan, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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