Stomach surgery shows promise for Drug-Resistant gastroparesis
NCT ID NCT04869670
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a procedure called G-POEM, which uses a scope to cut the pylorus muscle, against a sham surgery in people with severe gastroparesis (stomach paralysis) that did not improve with medication. Only 3 patients enrolled before the study ended early. The goal was to see if G-POEM safely reduces nausea, bloating, and stomach pain over 12 months and improves quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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3 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Mar 2025
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration. * Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 at screening visit. * Refractory gastroparesis, defined using our previously published data5, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3 antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone). * Moderate to severe delay in gastric emptying, defined as \> 25% solid retained at 4 hours or \> 75% retained at 2 hours. The qualifying gastric emptying scintigraphy must be performed within 18 months prior to registration or can be the baseline gastric emptying. * No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history. Exclusion Criteria: * Another active disorder which could explain symptoms in the opinion of the investigator. * Gastric retention of solids at 4 hours \< 25% or \< 75% at 2 hours. * Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) GLP -1 analog or agonists, or drugs that slow down gastric emptying (narcotics). Neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline) or others that are being used at stable doses for a month prior to randomization may continue at the discretion of the care provider. * Significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by Child-Pugh score of 10 or greater. * Poorly controlled diabetes with HbA1c of greater than 10% at time of screening. * New medications for gastroparesis-related symptoms started within 1 month prior to registration. * Pregnancy or nursing. * Failure to give informed consent. * Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study. * Botox injection into the pylorus within 3 months prior to registration. * Allergy to eggs or Egg Beaters and Ensure.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
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Other studies related to the condition(s) this trial covers.
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