Endoscopic Myotomy of the Pylorus To Improve Emptying and Symptoms Trial (EMPTIES)

This is an interventional treatment trial for Gastroparesis Read More

Inclusion Criteria:

1. Male or female, aged 18-65
2. Diagnosis of medically refractive gastroparesis by 4-hour non-extrapolated solid phase gastric emptying study within 90 days
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. Ability to speak and read in the English Language

Exclusion Criteria:

1. Active use of narcotic pain medication
2. Presence of concomitant gastrointestinal transit disorder such as small bowel or colonic dysmotility
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 other anticoagulant medications (with the exception of antiplatelet therapy)