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NCT04880473 · ClinicalTrials.gov registry record · NA
Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment
A NA study of Gastrointestinal Complication, sponsored by Entac Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 400
- Enrollment target
- 8
- Study locations
NCT04880473 is a NA study of Gastrointestinal Complication that is actively recruiting participants, run by Entac Medical. The registered enrollment target is 400 participants. The trial reports 8 study locations across 7 states.
The verdict
NCT04880473, a NA study of Gastrointestinal Complication, is actively recruiting participants, sponsored by Entac Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
- 8
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. 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.
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.
NCT04880473 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Minnesota, Florida, Illinois.
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.
What interventions are being tested in trial NCT04880473?
The interventions under investigation include: PrevisEA device (DEVICE).
Who is sponsoring clinical trial NCT04880473?
This trial is sponsored by Entac Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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