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Can a stomach biopsy predict who will respond to gastric pacemakers?

NCT ID NCT02165059

Knowledge-focused Sponsor: Indiana University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study collects small tissue samples from the stomach and upper intestine of people with severe gastroparesis (delayed stomach emptying). Researchers look for specific cell abnormalities that might predict whether a patient will benefit from a gastric electrical stimulation device. The goal is to better understand the disease and improve treatment decisions.

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.

Participants

About 300 people

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

Started

Dec 2013

Expected to finish

Dec 2026

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.

Who is studied

Patients who have been diagnosed with gastropareiss and are undergoing surgery for full thickness biopsy GES implantation willl serve as our study group, Patients who are undergoing surgery on the digestive system but do not have gastroparesis, will serve as our control group.

Ages

6 months to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 Study Group: Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal jejunum for the clinical evaluation of GI neuromuscular disorder. Inclusion Criteria Control Group: Patients undergoing esophagectomy, sleeve gastrectomy for obesity, or Roux-en Y gastric bypass Patients undergoing Whipple surgery Patients undergoing transplant surgery Patients who are organ donors and undergoing surgery Exclusion Criteria Study Group: Contraindication for surgical full-thickness biopsy for any reason. Significant comorbidity due to severe cardiovascular, renal, pulmonary, or liver disease. Significant coagulopathy Non-ambulatory patients: bed-ridden, nursing home resident. Pregnant Unable to give own informed consent Prisoners Exclusion Criteria Control Group: Prior diagnosis of gastroparesis Prior diagnosis of chronic intestinal pseudo-obstruction Unable to give own informed consent if not an organ donor

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease gastroparesis Nausea Vomiting

As listed by the trial registrant

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

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

  • Indiana University Hosptial

    RECRUITING

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

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