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New procedure offers hope for stomach paralysis sufferers

NCT ID NCT05039424

Symptom relief Sponsor: Matthew Allemang 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Updated 2 times

Summary

This study tests a procedure called per-oral pyloromyotomy (POP) to see if it helps people with gastroparesis, a condition where the stomach empties too slowly. About 100 adults who have not improved with standard treatment will be randomly assigned to either the real procedure or a sham (fake) procedure. The main goal is to measure changes in stomach symptoms and emptying over 12 weeks.

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 100 people

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

Started

Feb 2022

Expected to finish

Mar 2027

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 to 75 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: 1. Male or female, aged 18-75 2. Diagnosis of medically refractory gastroparesis by 4 hour non-extrapolated solid phase gastric emptying study completed within 12 months of enrollment. Medical refractoriness is defined by at least 6 months of medical treatment with no significant improvement in baseline symptoms 3. Completion of all routine assessments in our multidisciplinary gastroparesis clinic, which includes evaluation by gastroenterology, behavioral health, and nutrition specialists 4. Ability to take oral medication and be willing to adhere to the post-procedure dietary and medication regimen 5. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation 6. Stated willingness to comply with all study procedures and availability for the duration of the study 7. Willingness and reasonable expectation that the individual will be able to travel to the study site for the intervention and each scheduled in-person assessment, as well as virtual assessments if necessary 8. Be able to speak and read the English language. Exclusion Criteria: 1. Active use of narcotic pain medication 2. Presence of concomitant gastrointestinal transit disorder such as small bowel dysmotility or uncontrolled colonic dysmotility (As defined by clinical judgement or \< 3 bowel movements per week) 3. Etiology of gastroparesis is post-surgical 4. Pregnancy or lactation 5. History of egg allergy 6. Prior surgical intervention of the stomach or gastric pylorus 7. Current parenteral nutrition 8. Uncontrolled coagulopathy (platelet count \<50,000 and INR\>1.5) or use of anticoagulant medications (with the exception of antiplatelet therapy)

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Conditions

The condition(s) this trial relates to.

gastroparesis

As listed by the trial registrant

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

Gastroparesis

Contacts and locations

Locations

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.