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


About this study

The primary aim of this pilot and feasibility, hypothesis-generating study therefore is to evaluate the effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham endoscopic surgery on symptoms in patients with diabetic or idiopathic gastroparesis.

Gastroparesis is a disorder of gastric function characterized by delay in gastric emptying, frequently associated with chronic nausea and vomiting, early satiety, postprandial fullness, abdominal pain, and malnutrition that may require nutritional support. There are few effective treatments available; more recently, a procedure called G-POEM (gastric peroral endoscopic myotomy) has been advocated to relieve symptoms by improving gastric emptying; however, it is not clear whether this is safe or effective.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.


Inclusion Criteria:

  • Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) 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 at screening visit.
  • Refractory gastroparesis, defined using our previously published data5, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3  antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone).
  •  Moderate to severe delay in gastric emptying, defined as > 25% solid retained at 4 hours or > 75%retained at 2 hours. The qualifying gastric emptying scintigraphy must be performed within 18 months prior to registration or can be the baseline gastric emptying.
  • No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history.

Exclusion Criteria:

  • Another active disorder which could explain symptoms in the opinion of the investigator.
  • 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 may continue at the discretion of the care provider..
  • Significant systemic illness such as chronic renal failure (adjusted for age) or liver 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 to registration.
  • Pregnancy or nursing.
  • Failure to give informed consent.
  • Any other condition, which in the opinion of the investigator would impede compliance 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.

Eligibility last updated 10/25/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D., D.Sc.

Closed-enrolling by invitation

What is this? (?)
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Deborah Eckert R.N.

(507) 538-5860


Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Pankaj Pasricha, M.B.B.S., M.D.

Closed-enrolling by invitation

What is this? (?)
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Guillermo Barahona Hernandez

(410) 603-8343


More information


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