New hope for stomach paralysis? trial combines two procedures
NCT ID NCT07526935
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two procedures—G-POEM and a gastric electrical stimulator—for people with severe gastroparesis (stomach paralysis) that hasn't improved with medication. Forty adults will be randomly assigned to one of two groups to compare safety and symptom relief. The goal is to see if these treatments can improve stomach emptying and quality of life.
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 stimulator and gastric peroral endoscopic myotomy (G-POEM)
- What this could lead to
- If successful, this could offer a new treatment option for people with severe stomach paralysis that doesn't respond to medication.
- What could go wrong
- This is a small, early-stage trial with only 40 people, so results may not apply to everyone. The procedures are invasive and carry risks like infection or bleeding.
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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- 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
-
18 years and older
- Sex
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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 Hide 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: * Adult patients of age 18 years and older * Patients must be able to consent * Documented diagnosis of refractory GP as determined by the following criteria: * Medically refractory GP symptoms for \> 1 year despite treatment with first-line modalities and pharmacotherapies with anti-emetics and prokinetics AND * Gastric emptying scintigraphy showing delayed gastric emptying with retention of \>60% at 2h and/or greater than 10% at 4h based on standardized radionuclide solid meal test * Preoperative Gastroparesis Cardinal Symptom Index (GCSI) Score * A decision to treat patient with surgical therapy of G-POEM and/or electric stimulator Exclusion Criteria: * Patients with prior surgical intervention for gastroparesis * Patients less than 18 years old * Pregnant women
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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
-
Baylor University Medical Center
Dallas, Texas, 75246, United States
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