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A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis | Clinical Trials | Clareo Health

COMPLETEDNA

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

A Pilot and Feasibility Trial of G-POEM for Gastroparesis to Assess Safety, Physiological Mechanisms and Efficacy

NCT04869670•Mayo Clinic

Summary

The purpose of this research is to evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham surgery in patients with gastroparesis that is not helped by medications and to analyze factors that may predict the outcome of the surgery.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (2)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

July 12, 2023

Primary Completion Date

March 3, 2025

Completion Date

March 3, 2025

Last Updated

March 5, 2025

Enrollment

ACTUAL participants

Conditions

Gastroparesis

Interventions

Gastric peroral endoscopic myotomy.

PROCEDURE

Sham Gastric peroral endoscopic myotomy.

PROCEDURE

Gastroparesis Outcome Longitudinal Database Enrolled Numerically

NCT03876288

Gastroparesis

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RECRUITINGEARLY_PHASE1

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RECRUITINGNA

Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Gastroparesis Outcome Longitudinal Database Enrolled Numerically

Growth Hormone for the Treatment of Gastroparesis

Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes

Transpyloric Stenting As a Predictor for G-POEM for Refractory Gastroparesis

Different Doses of Naronapride Vs. Placebo in Gastroparesis

Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic Patients