Status:
WITHDRAWN
Use of EndoFLIP and Manometry Prior to G-POEM
Lead Sponsor:
Northwestern University
Conditions:
Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 lum...
Detailed Description
Gastroparesis is defined as an objective delay in gastric emptying in the absence of mechanical obstruction with corresponding cardinal symptoms of postprandial fullness, early satiety, nausea, vomiti...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04844190
Start Date
September 15 2021
End Date
March 1 2024
Last Update
September 22 2025
Active Locations (1)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611