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Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms Trial
Sponsor: Matthew Allemang
Summary
A randomized clinical trial comparing endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in patients with medically refractory gastroparesis.
Official title: A Randomized, Sham-controlled Trial: Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms (EMPTIES)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-02-23
Completion Date
2026-07
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
Endoscopic per-oral pyloromyotomy (POP)
Per-oral pyloromyotomy (POP), alternatively knows as gastric per-oral endoscopic myotomy (G-POEM), accomplishes longitudinal division of the pylorus using an endoscope. This procedure involves utilizing endoscopic electrosurgical knife to make an incision in the gastric mucosa and develop a submucosal tunnel to visualize the pyloric ring. The pyloric ring is divided longitudinally, and the mucosotomy incision is sealed with endoscopic clips.
Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption
While under general anesthesia, a standard gastroscope is introduced and a diagnostic upper endoscopy is performed. The operator talks through the procedure steps as if completing POP. The gastroscope is withdrawn and the patient is extubated.
Locations (1)
Cleveland Clinic Foundation
Cleveland, Ohio, United States