Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05039424
NA

Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms Trial

Sponsor: Matthew Allemang

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

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 The gastroscope is withdrawn and the patient is extubated.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