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Could a 'Stomach Pacemaker' stop Kids' chronic nausea?

NCT ID NCT07474415

Symptom relief Sponsor: Nationwide Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a device that sends small electrical pulses to the stomach can help children with severe, long-lasting nausea and vomiting. Thirty kids who hadn't gotten better with standard treatments took part. Each child had a temporary pacing lead placed through a tube into the stomach, and the device was turned off for four days and on for four days without them knowing which phase they were in. Researchers measured symptoms and how much the kids could eat or drink to see if the stimulation made a difference.

What this could mean

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

Active substance
gastric electrical stimulation device
What this could lead to
If it works, this could offer a new treatment option for children with severe nausea and vomiting that hasn't responded to standard care.
What could go wrong
This is a small, early-stage study with only 30 participants. The results may not apply to all children, and the temporary nature of the stimulation means long-term effects are unknown.

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

30 people

The number who actually took part.

Started

Nov 2019

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Up to 21 years

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: * Age \< 21 years * History of chronic nausea and vomiting refractory to medical therapy for at least 12 months * Symptoms severe enough to impact overall condition (e.g., weight loss or need for dietary modification) * Ability of participant and/or parent/guardian to provide informed consent/assent Exclusion Criteria: * Mechanical obstruction of the gastrointestinal tract. * Diagnosis of an eating disorder * Psychiatric condition deemed by the medical team to pose a safety concern for study participation * Inability of the participant to communicate symptoms * Inability of the participant or parent/guardian to read or speak English

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Conditions

The condition(s) this trial relates to.

cyclic vomiting syndrome dyspepsia functional gastric disease gastroparesis Nausea Vomiting

As listed by the trial registrant

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

Functional dyspepsia Gastroparesis Vomiting syndrome

Contacts and locations

Locations

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

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