A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis

Inclusion Criteria:

• Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic ordiabetic) must be present for at least one year (does not have to be contiguous)prior to registration.

• Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 atscreening visit.

• Refractory gastroparesis, defined using our previously published data5, as a failureto improve over the last 6 months, despite an adequate trial of one or more standardprokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone).

• Moderate to severe delay in gastric emptying, defined as > 25% solid retained at 4hours or > 75% retained at 2 hours. The qualifying gastric emptying scintigraphymust be performed within 18 months prior to registration or can be the baselinegastric emptying.

• No evidence of mechanical obstruction based on upper GI endoscopy or upper GI seriesin their medical history.

Exclusion Criteria:

• Another active disorder which could explain symptoms in the opinion of theinvestigator.

• Gastric retention of solids at 4 hours < 25% or < 75% at 2 hours.

• Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride)GLP -1 analog or agonists, or drugs that slow down gastric emptying (narcotics).Neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline)or others that are being used at stable doses for a month prior to randomization maycontinue at the discretion of the care provider.

• Significant systemic illness such as chronic renal failure (adjusted for age) orliver disease as defined by Child-Pugh score of 10 or greater.

• Poorly controlled diabetes with HbA1c of greater than 10% at time of screening.

• New medications for gastroparesis-related symptoms started within 1 month prior toregistration.

• Pregnancy or nursing.

• Failure to give informed consent.

• Any other condition, which in the opinion of the investigator would impedecompliance or hinder completion of the study.

• Botox injection into the pylorus within 3 months prior to registration.

• Allergy to eggs or Egg Beaters and Ensure.