← Back to Search

Procedure

Endoscopic Pyloromyotomy for Gastroparesis (EMPTIES Trial)

N/A
Recruiting
Led By Matthew Allemang, MD
Research Sponsored by Matthew Allemang
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged 18-65
Be older than 18 years old
Must not have
Current parenteral nutrition
Uncontrolled coagulopathy (platelet count <50,000 and INR>1.5) or use of anticoagulant medications (with the exception of antiplatelet therapy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline,12 weeks post-procedure
Awards & highlights

Summary

This trial compares two different treatments for gastroparesis, a condition where the stomach can't empty properly.

Who is the study for?
This trial is for adults aged 18-75 with severe gastroparesis not improved by at least 6 months of medical treatment. Participants must be able to travel for assessments, take oral meds, follow dietary/medication regimens post-procedure, and use effective contraception if applicable. Excluded are those with post-surgical gastroparesis, pregnant or breastfeeding individuals, uncontrolled blood clotting issues, egg allergies, prior stomach surgeries or on parenteral nutrition.
What is being tested?
The study compares an endoscopic procedure called per-oral pyloromyotomy (POP), which cuts the muscle at the stomach exit to improve emptying against a sham intervention without this cut in patients with tough-to-treat gastroparesis.
What are the potential side effects?
Possible side effects include sore throat from the scope used during procedures; risks associated with sedation; abdominal pain; infection risk at the incision site; bleeding or perforation of the stomach lining.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am receiving nutrition through an IV.
Select...
I do not have a bleeding disorder and am not on strong blood thinners.
Select...
I have had surgery on my stomach or the gastric pylorus.
Select...
My slow stomach emptying is due to a past surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline,12 weeks post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,12 weeks post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Gastroparesis Cardinal Symptom Index (GCSI)
Secondary study objectives
36-Item Short Form; Quality of Life Survey
Gastric Emptying

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Endoscopic per-oral pyloromyotomy (POP)Active Control1 Intervention
Participants will undergo Endoscopic per-oral pyloromyotomy (POP).
Group II: Sham / Control ArmPlacebo Group2 Interventions
Participants will undergo a diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption. Following the 12-week blinded trial period, these participants will be unblinded and offered Endoscopic per-oral pyloromyotomy (POP) if they remain symptomatic.

Find a Location

Who is running the clinical trial?

Matthew AllemangLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Gastroparesis
40 Patients Enrolled for Gastroparesis
The Cleveland ClinicLead Sponsor
1,047 Previous Clinical Trials
1,370,619 Total Patients Enrolled
2 Trials studying Gastroparesis
160 Patients Enrolled for Gastroparesis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,418 Previous Clinical Trials
4,325,674 Total Patients Enrolled
19 Trials studying Gastroparesis
3,046 Patients Enrolled for Gastroparesis

Media Library

Endoscopic per-oral pyloromyotomy (POP) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05039424 — N/A
Gastroparesis Research Study Groups: Endoscopic per-oral pyloromyotomy (POP), Sham / Control Arm
Gastroparesis Clinical Trial 2023: Endoscopic per-oral pyloromyotomy (POP) Highlights & Side Effects. Trial Name: NCT05039424 — N/A
Endoscopic per-oral pyloromyotomy (POP) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05039424 — N/A
~40 spots leftby Jul 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top