RecruitingNAINTERVENTIONAL

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

This research study is investigating a treatment called the Enterra Therapy System for people who experience long-term sickness and vomiting. These symptoms can be very disruptive, even when tests show their stomach empties food at a normal rate. The main goal of the study is to find out if this system can effectively lessen feelings of nausea and reduce how often someone vomits. Researchers also want to understand if using the Enterra System can lead to a better quality of life for those affected. Participants will have the device implanted and then track their symptoms and wellbeing over about a year, helping us learn more about this potential treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Enterra Medical, Inc.

Enrolment target

148

Start

23 Jun 2025

Estimated completion

01 Jun 2030

Nausea Vomiting

What is this study about?

This study is about understanding if a special treatment, called the Enterra® Therapy System, can help people who have ongoing problems with feeling sick (nausea) and being sick (vomiting). These symptoms can be very hard to live with, especially when they continue for a long time. Doctors have found that sometimes, even if tests show your stomach is emptying food normally, you can still suffer from chronic nausea and vomiting.

The Enterra® Therapy System works by sending mild electrical pulses to the stomach. The idea is that these pulses might help to settle the stomach and reduce those unpleasant symptoms. This study aims to carefully check if the system not only decreases nausea and vomiting but also makes a noticeable difference to how people feel generally and their overall quality of life.

By taking part, you would be helping researchers learn more about how to treat chronic nausea and vomiting. This knowledge could eventually benefit many others who struggle with these conditions in the future.

Key takeaways

Studies a device (Enterra System) for long-term sickness and vomiting.
Aims to reduce symptoms and improve quality of life.
For those with ongoing nausea, even if stomach emptying is normal.
Involves surgery to implant the device.
Requires daily symptom tracking on a smart device.
Participation lasts an average of 12 months.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been experiencing ongoing, difficult-to-treat nausea for more than six months, with symptoms still active in the last three months. You should also have tried at least two different types of anti-sickness medications without enough success, and importantly, your stomach should be emptying food at a normal speed according to recent tests.

It's important that you don't have any major blockages, ulcers, or growths in your food pipe, stomach, or upper bowel. Also, if you've had a specific stomach procedure called pyloric transection, it needs to have been more than a year ago. The doctors will also check that you are generally well and that no major changes to your other medications are planned during the study.

There are also some reasons why you might not be able to join, such as if you have memory problems, certain gut conditions like blockages, or specific eating disorders or causes of vomiting that aren't related to stomach emptying.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Have you had ongoing nausea for more than 6 months?
Have you tried at least two types of anti-sickness medicines without enough relief?
Do recent stomach tests show your stomach empties food normally?
Are you generally well and able to use a smart device daily?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step would involve having the Enterra® Therapy System surgically placed into your body. After this, you would be assigned to a specific study group. You would then use a smart device (like a smartphone or tablet) to answer daily questions about how you're feeling, including your nausea and vomiting symptoms, and how these affect your daily life.

You would also attend regular clinic visits where you would complete questionnaires about your symptoms and general wellbeing. The study is designed to last for about 12 months after you've been assigned to your study group. Throughout this time, your health will be carefully monitored.

Potential risks and benefits

Participating in research studies always carries potential benefits and risks. A potential benefit of taking part in this study could be that your nausea and vomiting symptoms improve, leading to a better quality of life. However, there's also a chance the treatment may not work for you, or it might not provide the improvements hoped for. As the Enterra® Therapy System is implanted, there are risks associated with surgery, such as infection or pain. You will be fully informed about all known risks before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (22)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Mayo Clinic Arizona
Verified postcode
Scottsdale, United States· Recruiting
Keck Medicine of USC
Verified postcode
Los Angeles, United States· Recruiting
Hoag Hospital
Verified postcode
Newport Beach, United States· Recruiting
Sutter Health
Verified postcode
San Francisco, United States· Recruiting
University of South Florida
Verified postcode
Tampa, United States· Recruiting
Endeavor Health
Verified postcode
Evanston, United States· Recruiting
Indiana University Health
Verified postcode
Indianapolis, United States· Recruiting
University of Louisville
Verified postcode
Louisville, United States· Recruiting
Hackensack Meridian
Verified postcode
Neptune City, United States· Recruiting
Cleveland Clinic Foundation
Verified postcode
Cleveland, United States· Recruiting
Temple Digestive Disease Center
Verified postcode
Philadelphia, United States· Recruiting
Baylor College of Medicine
Verified postcode
Houston, United States· Recruiting

Common questions

What is the Enterra Therapy System?

It's a small device that's surgically placed in your body to send mild electrical pulses to your stomach, aiming to reduce nausea and vomiting.

How long will I be in the study?

You will be involved for about 12 months (one year) after you start in your study group.

Will I have to have surgery?

Yes, part of the study involves having the Enterra Therapy System surgically implanted.

Do I need a smartphone to participate?

Yes, you'll need to use a smart device, like a smartphone or tablet, to log your symptoms daily.

What if the treatment doesn't work for me?

There's no guarantee the treatment will work for everyone, but the study helps us understand its effectiveness. You can also withdraw from the study at any time.

How to find out more

Timothy McAllister

clinicalresearch@enterramedical.com 855-768-3772 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.