Trials / Active Not Recruiting
Active Not RecruitingNCT05039424
Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms Trial
A Randomized, Sham-controlled Trial: Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms (EMPTIES)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Matthew Allemang · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
A comparative effectiveness, single center (with two surgical units), randomized (1:1) study of endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in adult patients with medically refractory gastroparesis who have failed management with dietary, lifestyle, and pharmacological therapy for at least six months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 The gastroscope is withdrawn and the patient is extubated. |
Timeline
- Start date
- 2022-02-23
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
- First posted
- 2021-09-09
- Last updated
- 2026-01-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05039424. Inclusion in this directory is not an endorsement.