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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

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

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am receiving nutrition through an IV.

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I do not have a bleeding disorder and am not on strong blood thinners.

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I have had surgery on my stomach or the gastric pylorus.

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My slow stomach emptying is due to a past surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline,12 weeks post-procedure

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.

0 / 5Eligibility criteria met