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Could a tweak to an implanted device ease stomach pain?

NCT ID NCT07556237

Symptom relief Sponsor: University of Louisville 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether changing the settings on an already-implanted stomach pacemaker (Enterra™) can reduce chronic abdominal pain in people with gastroparesis, a condition where the stomach empties slowly. Researchers will randomly assign 150 adults to one of three stimulation programs and track their pain, symptoms, and quality of life over 8 weeks. The goal is to find a better way to manage pain without extra medications.

What this could mean

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

Active substance
Enterra™ neurostimulator (implanted device)
What this could lead to
If successful, this could provide a new way to manage chronic abdominal pain in people with gastroparesis without adding new drugs.
What could go wrong
This is a small, early-stage study testing different programming settings on an already-approved device. It may not show a clear benefit for pain, and results may not apply to everyone with gastroparesis.

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 150 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

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

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: * Adults aged 18 years or older. * Diagnosed gastroparesis. * Implanted Enterra™ device for at least 8 weeks prior to enrollment. * Chronic daily abdominal pain of gastric origin lasting more than 2 months. * Average pain score ≥4 on a 0-10 scale. * Ability to provide informed consent. Exclusion Criteria: * Daily opioid use. * Pregnancy or breastfeeding. * Abdominal pain not attributed to gastric/visceral origin. * Severe constipation or uncontrolled diabetes (HbA1c \>10). * Other medical conditions that would interfere with study participation.

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Conditions

The condition(s) this trial relates to.

gastroparesis Visceral Pain

As listed by the trial registrant

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

Chronic abdominal pain Gastroparesis

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • University of Louisville Clinical Trials Unit

    Louisville, Kentucky, 40202, United States

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