RecruitingNot ApplicableNCT06464926

Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)

A Prospective Randomized Controlled Trial of Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System


Sponsor

Enterra Medical, Inc.

Enrollment

148 participants

Start Date

Jun 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to determine if the Enterra® Therapy System can decrease nausea and vomiting symptoms and improve the quality of life for patients with chronic nausea, with or without vomiting, that have normal gastric emptying.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Enterra Therapy System for people with nausea and vomiting. The study is currently recruiting participants at 22 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEnterra Therapy System

The Enterra Therapy System is a gastric electrical stimulator system consisting of an implantable pulse generator (Enterra II Model 37800 neurostimulator); two implantable unipolar leads (Enterra Model 4351-35 intramuscular); and device programmer (N'Vision Clinician Programmer Model 8840 with Model 8870 Application Card). The programmable neurostimulator operates on a sealed battery and electronic circuitry to provide controlled electrical pulse stimulation through the implanted lead system. A clinician programmer is used to program the neurostimulator and adjust stimulation settings to programmable parameters and stimulation options.


Locations(22)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Keck Medicine of USC

Los Angeles, California, United States

Hoag Hospital

Newport Beach, California, United States

Sutter Health

San Francisco, California, United States

University of South Florida

Tampa, Florida, United States

Endeavor Health

Evanston, Illinois, United States

Indiana University Health

Indianapolis, Indiana, United States

University of Louisville

Louisville, Kentucky, United States

Hackensack Meridian

Neptune City, New Jersey, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Temple Digestive Disease Center

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

UZ Leuven

Leuven, Belgium

Hôpital Louis-Mourier

Colombes, France

Hôpital Edouard Herriot - CHU de Lyon

Lyon, France

CHU de Bordeaux

Pessac, France

CHU de Rouen

Rouen, France

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

University College London Hospital

London, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Functional Gut Clinic

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06464926


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