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Stomach pacemaker could quiet chronic nausea

NCT ID NCT06464926

Symptom relief Sponsor: Enterra Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a device called the Enterra Therapy System, which is like a pacemaker for the stomach, can reduce chronic nausea and vomiting in people whose stomach empties normally. The device is surgically implanted and sends mild electrical pulses to the stomach. The trial will enroll 148 adults who have had nausea for at least 6 months and haven't gotten relief from drugs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Enterra Therapy System (implantable gastric electrical stimulator)
What this could lead to
If it works, this could offer a new treatment option for people with chronic nausea and vomiting that hasn't responded to drugs.
What could go wrong
This is an early-stage trial with only 148 participants. The device requires surgery and carries risks like infection or lead problems. It may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 148 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Willing and able to complete the informed consent process * Stated willingness to comply with all study procedures and availability for the duration of the study * Aged ≥18 years at time of informed consent * Chronic, drug-refractory nausea that: a) has been present for more than 6 months, and b) has been active within the last 3 months prior to consent * Patient is able to complete ANMS GCSI-DD surveys on a compatible smart device with: a) a minimum of four (4) ANMS GCSI-DD entries per week for two consecutive weeks, and b) an average ANMS GCSI-DD score for nausea severity of ≥2.5 during the same two-week period * Refractory or intolerant to two or more of the following antiemetic drug classes: antihistamines, phenothiazines, serotonin type 3 receptor antagonists, dopamine type 2 receptor antagonists, anticholinergics, neurokinin receptor antagonists * Medically stable, in the opinion of the investigator, during the month prior to consent, with no planned modifications to medical therapy during the course of the study * Normal gastric emptying as assessed by a qualifying gastric emptying test performed within 2 years of consent if no prior pyloric transection therapy, or within 2 years of consent and after the most recent pyloric transection therapy * Normal upper endoscopy within 1 year prior to consent (e.g., absence of obstructions, ulcers, or cancers in the esophagus, stomach, or duodenum) performed within 1 year of consent if no prior pyloric transection therapy, or within 1 year of consent and after the most recent pyloric transection therapy Exclusion Criteria: * Cognitive impairment or other characteristic that would limit a patient's ability to complete study requirements * Pyloric transection therapy completed within 1 year of consent * Documented gastrointestinal (GI) obstruction or pseudo-obstruction * History of primary swallowing disorders * History of primary psychogenic vomiting * History of primary eating disorder * History of cyclic vomiting syndrome * History of rumination syndrome * History of scleroderma * History of amyloidosis * History of cannabis hyperemesis syndrome * Active H. pylori infection * Evidence of bezoar during most recent endoscopy * Previous gastric surgery of any type other than a pyloric transection therapy (i.e., pyloroplasty, pyloromyotomy, POP, or G-POEM) * Uncontrolled thyroid disorder, in the opinion of the investigator * History of seizures disorders * Hemoglobin A1c \>8.0% * Peritoneal dialysis or unstable hemodialysis * Parenteral or enteral nutritional support * Active pancreatitis * History of organ transplant, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease * Other GI tract diseases and disorders that the investigator believes may have caused the patient's drug-refractory nausea and/or vomiting * Malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of consent * Opioid use * Current cannabis/cannabinoid use that exceeds: 3 days of usage per week, or 2 occurrences during each day of use, or 3 grams of total usage per week * Heavy alcohol use, defined as: for men, consuming five or more drinks on any day or 15 or more per week; for women, consuming four or more drinks on any day or 8 or more per week * Injection of Botox into the pyloric sphincter within 6 months of consent * Active major levels of anxiety/depression, as determined by the investigator * History of other clinically significant disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the patient or impact the validity of the study results * Life expectancy \<1 year * Pregnant or breastfeeding at the time of consent or intend to become pregnant during the study * Any underlying disease leading to follow-up by MRI outside of current MR conditional indications * Glucagon-like peptide 1 (GLP-1) agonist drug use within 6 months of consent * Participation in other investigational clinical studies * Existing or prior gastric electrical stimulator implantation

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome Nausea Vomiting

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nausea Vomiting

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    22 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • CHU de Bordeaux

    RECRUITING

    Pessac, France

  • CHU de Rouen

    RECRUITING

    Rouen, 76031, France

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Endeavor Health

    RECRUITING

    Evanston, Illinois, 60201, United States

  • Functional Gut Clinic

    RECRUITING

    Manchester, M3 4BG, United Kingdom

  • Hackensack Meridian

    RECRUITING

    Neptune City, New Jersey, 07753, United States

  • Hoag Hospital

    RECRUITING

    Newport Beach, California, 92663, United States

  • Hôpital Edouard Herriot - CHU de Lyon

    RECRUITING

    Lyon, 69003, France

  • Hôpital Louis-Mourier

    RECRUITING

    Colombes, France

  • Indiana University Health

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Keck Medicine of USC

    RECRUITING

    Los Angeles, California, 90033, United States

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Manchester University NHS Foundation Trust

    RECRUITING

    Manchester, M23 9LT, United Kingdom

  • Mayo Clinic Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Sahlgrenska Universitetssjukhuset

    RECRUITING

    Gothenburg, 413 45, Sweden

  • Sutter Health

    RECRUITING

    San Francisco, California, 94109, United States

  • Temple Digestive Disease Center

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • UZ Leuven

    RECRUITING

    Leuven, Belgium

  • University College London Hospital

    RECRUITING

    London, NW1 6DB, United Kingdom

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

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