CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 100 target
Drug / intervention
Endoscopic per-oral pyloromyotomy (POP) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05039424
NCT05039424N/AActive
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A Randomized, Sham-controlled Trial: Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms (EMPTIES)

Matthew Allemang·interventional·Posted Sep 9, 2021·Updated Jan 26, 2026

In Brief

A clinical study evaluating Endoscopic per-oral pyloromyotomy (POP) and Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption for Gastroparesis. Active but no longer recruiting, targeting 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroparesis
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/AActiveOverdue
20222023202420252026
First PostedSep 9, 2021
Enrollment StartFeb 23, 2022
Primary CompletionJul 1, 2026
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 4.8 years ago

Interventions

Endoscopic per-oral pyloromyotomy (POP)procedure

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 disruptionprocedure

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 The gastroscope is withdrawn and the patient is extubated.