Gastroparesis procedure prediction study pulled before starting
NCT ID NCT04844190
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study aimed to find out if two tests—EndoFLIP and antroduodenal manometry—could predict which patients with severe gastroparesis would benefit from a procedure called G-POEM. The plan was to measure stomach muscle activity and pressure before the procedure. However, the study was withdrawn before any participants were enrolled, so no results are available.
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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.
- Started
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Sep 2021
- Finished
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Mar 2024
- 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 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * All patients aged 18+ diagnosed with refractory gastroparesis as defined earlier in this document, no age limit * Patients already consented to undergo G-POEM Exclusion Criteria: * Patients who are pregnant(at Northwestern, all female patients have urine pregnancy tests on day of endoscopy), vulnerable populations such as prisoners, * Life expectancy \< 1 year based on concurrent comorbidities based on study team assessment, * Coagulopathy with INR \> 1.5 that cannot be reversed, * Thrombocytopenia with platelets \< 50,000 that cannot be corrected with blood products, * Unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope. * Patients with history of gastric surgery and * Active narcotic use at time of G-POEM evaluation within four weeks. Tobacco use is not an exclusion criterion
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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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Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
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Other studies related to the condition(s) this trial covers.
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