Use of EndoFLIP and Manometry Prior to G-POEM
Reason given: Unable to complete study procedures due to staffing issues.
Key facts
- Where
- Chicago, United StatesSee the site
Where in United States
- Northwestern Memorial HospitalChicago, United StatesNo longer taking part
Trial details
- Who runs it
- Northwestern University
- Trial code
- NCT04844190
- Record updated
- 22 September 2025
- Original description
The purpose of this study is to assess physiologic response of therapy in patients with refractory gastroparesis undergoing Gastric per-oral endoscopic myotomy (G-POEM) using endoscopic functional lumen imaging probe (EndoFLIP) and antroduodenal manometry (ADM). Refractory gastroparesis will be defined as having delayed gastric emptying at four hours (>10% retention of stomach contents) on gastric scintigraphy and persistent symptoms despite treatment with dietary modification or prokinetic medications. We hypothesize that EndoFLIP and high resolution ADM will provide an individualized pyloric functional profile in gastroparesis patients that can more accurately predict clinical response to G-POEM.Read full original descriptionShow less
Use of Endoscopic Functional Lumen Imaging Probe (EndoFLIP) and Antroduodenal Manometry (ADM) in Predicting Clinical Response to Gastric Peroral Endoscopic Myotomy (G-POEM): A Pilot Study
The purpose of this study is to assess physiologic response of therapy in patients with refractory gastroparesis undergoing Gastric per-oral endoscopic myotomy (G-POEM) using endoscopic functional lumen imaging probe (EndoFLIP) and antroduodenal manometry (ADM). Refractory gastroparesis will be defined as having delayed gastric emptying at four hours (>10% retention of stomach contents) on gastric scintigraphy and persistent symptoms despite treatment with dietary modification or prokinetic medications. We hypothesize that EndoFLIP and high resolution ADM will provide an individualized pyloric functional profile in gastroparesis patients that can more accurately predict clinical response to G-POEM.
Inclusion: 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: Life expectancy < 1 year based on concurrent comorbidities based on study team assessment,; Patients with history of gastric surgery and; Coagulopathy with INR > 1.5 that cannot be reversed,; Thrombocytopenia with platelets < 50,000 that cannot be corrected with blood products,; Patients who are pregnant(at Northwestern, all female patients have urine pregnancy tests on day of endoscopy), vulnerable populations such as prisoners,; Unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope; Active narcotic use at time of G-POEM evaluation within four weeks. Tobacco use is not an exclusion criterion.