Clinical Trials Logo
  1. Home
  2. Gastrointestinal Complication
  3. NCT04880473

Evaluation of the PrevisEA Device for Predicting Gastrointestinal Impairment

Gastrointestinal Complication Clinical Trial

Official title:
A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04880473
Study type Interventional
Source Entac Medical Inc.
Contact Entac Medical Inc.
Phone 845-773-8473
Email previsea-001@clinicalresearchstrategies.com
Status Recruiting
Phase N/A
Start date September 14, 2021
Completion date December 1, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT00936130 - Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity N/A
Completed NCT03678987 - Mycophenolate Mofetil Pharmacokinetics in Systemic Sclerosis
Completed NCT04590768 - Tolerance of Regular Meal Intake With Mycoprotein (TOMMY) N/A
Completed NCT03677583 - Duckweed Intake Study N/A
Recruiting NCT04192435 - Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery Phase 4
Completed NCT06165523 - Kefir Versus Milk on Time-Trial Performance in Masters Athletes N/A
Recruiting NCT06072976 - The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies N/A
Recruiting NCT03848962 - Collection and Distribution of Biospecimens for Novel Research Uses
Recruiting NCT06250166 - Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design N/A
Enrolling by invitation NCT05080907 - Collection and Distribution of Biospecimens for Novel Research
Completed NCT02040285 - Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC) Phase 4
Completed NCT00814086 - Cisplatin and Paclitaxel in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Phase 1
Terminated NCT03100409 - Effect of a Low Residue Diet in Comparison to the Dietetic Recommendations From the INCan in Cervical Cancer Patients N/A
Recruiting NCT04903925 - Probiotics for Improving Post-surgical Healing N/A