Endoscopic procedure to improve stomach emptying in gastroparesis patients

A Randomized, Sham-controlled Trial: Endoscopic Myotomy of the Pylorus to Improve Emptying and Symptoms (EMPTIES)

This study tests if a new endoscopic procedure can help adults with gastroparesis who haven't found relief from other treatments by improving how their stomach empties.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT05039424 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the effectiveness of endoscopic per-oral pyloromyotomy (POP) against a control sham intervention in adults suffering from medically refractory gastroparesis. Participants will be randomly assigned to receive either the POP procedure or a diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption. The study aims to evaluate improvements in gastric emptying and associated symptoms after the intervention. Eligible patients must have previously failed dietary, lifestyle, and pharmacological treatments for at least six months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of medically refractory gastroparesis who have not responded to standard treatments.

Not a fit: Patients who have not been diagnosed with medically refractory gastroparesis or those who have not undergone prior medical management may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could significantly improve gastric emptying and alleviate symptoms for patients with refractory gastroparesis.

How similar studies have performed: Other studies have shown promise with similar endoscopic approaches, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Male or female, aged 18-75
2. Diagnosis of medically refractory gastroparesis by 4 hour non-extrapolated solid phase gastric emptying study completed within 12 months of enrollment. Medical refractoriness is defined by at least 6 months of medical treatment with no significant improvement in baseline symptoms
3. Completion of all routine assessments in our multidisciplinary gastroparesis clinic, which includes evaluation by gastroenterology, behavioral health, and nutrition specialists
4. Ability to take oral medication and be willing to adhere to the post-procedure dietary and medication regimen
5. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
6. Stated willingness to comply with all study procedures and availability for the duration of the study
7. Willingness and reasonable expectation that the individual will be able to travel to the study site for the intervention and each scheduled in-person assessment, as well as virtual assessments if necessary
8. Be able to speak and read the English language.

Exclusion Criteria:

1. Active use of narcotic pain medication
2. Presence of concomitant gastrointestinal transit disorder such as small bowel dysmotility or uncontrolled colonic dysmotility (As defined by clinical judgement or \< 3 bowel movements per week)
3. Etiology of gastroparesis is post-surgical
4. Pregnancy or lactation
5. History of egg allergy
6. Prior surgical intervention of the stomach or gastric pylorus
7. Current parenteral nutrition
8. Uncontrolled coagulopathy (platelet count \<50,000 and INR\>1.5) or use of anticoagulant medications (with the exception of antiplatelet therapy)

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Matthew Allemang, MD — The Cleveland Clinic
• Study coordinator: Karim Kheniser

Conditions Gastroparesis