Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator

Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator in the Management of Refractory Gastroparesis- A Randomized Single Blinded Control Trial

This study is looking at how safe and effective G-POEM, GES and a combination of both are for people with severe stomach problems (gastroparesis) that haven't gotten better with medicine.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastroparesis
• Intervention / Treatment: Device: GES + Upper endoscopy; Device: GES on + Upper endscopy; Procedure: GES off + G-POEM; Procedure: GES on + G-POEM

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients of age 18 years and older
• Patients must be able to consent
• Documented diagnosis of refractory GP as determined by the following criteria:
• Medically refractory GP symptoms for > 1 year despite treatment with first-line modalities and pharmacotherapies with anti-emetics and prokinetics AND
• Gastric emptying scintigraphy showing delayed gastric emptying with retention of >60% at 2h and/or greater than 10% at 4h based on standardized radionuclide solid meal test
• Preoperative Gastroparesis Cardinal Symptom Index (GCSI) Score
• A decision to treat patient with surgical therapy of G-POEM and/or electric stimulator

Exclusion Criteria:

• Patients with prior surgical intervention for gastroparesis
• Patients less than 18 years old
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; GES off + Upper Endoscopy	Device: GES + Upper endoscopy; Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement), without undergoing G-POEM. The stimulator will remain off for the first 6 months and will then be turned on for the following 6 months.
Active Comparator: GES only; GES on + Upper Endoscopy	Device: GES on + Upper endscopy; Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement), without undergoing G-POEM. The stimulator will stay on for the first 6 months and will then be turned off for the following 6 months.
Active Comparator: G-POEM only; GES off + GPOEM	Procedure: GES off + G-POEM; Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement) and G-POEM surgery. The stimulator will remain off for the first 6 months and will then be turned on for the following 6 months.
Active Comparator: Combination G-POEM and GES; GES on + GPOEM	Procedure: GES on + G-POEM; Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement) and G-POEM. POEM. The stimulator will stay on for the first 6 months and will then be turned on for the following 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastroparesis Symptom Changes	Monitoring changes in gastroparesis symptom severity as measured by the Gastroparesis Cardinal Symptom Index (GCSI). A 9-item patient reported questionnaire with a rating scale of 0-5 ranging from 0 (none) to 5 (very severe).	Baseline, Preoperative 3 months, 6 months, 9 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Assessing changes in weight using clinical measurement	Baseline, 6 months, 12 months
BMI	Assessing changes in BMI using clinical measurement	Baseline, 6 months, 12 months
Gastroparesis-related hospitalizations	Evaluating rates of reintervention/hospitalizations due to surgical complications by referring to subjects medical records	12 month follow-up
ED visits for symptoms	Evaluating number of ED visits, hospitalizations/readmissions due to gastroparesis by referring to subjects medical records	12 month follow-up
Gastric Emptying	Evaluating gastric emptying as shown in 4-hour retention on gastric emptying scintigraphy using the nuclear medicine report	Baseline, 6 months, 12 months
Antiemetic/Prokinetic use	Evaluating changes to pharmacologic use by monitoring active medication use via subjects medical records	Baseline, 6 months, 12 months
Subjects quality of life	Measuring changes to Quality of Life as measured by the 36-Item Short Form Survey (SF-36). A self-reported tool consisting of 36 questions with a rating scale of 0 (worst health) to 100 (best health).	Baseline, 6 months, 12 months.
Nutritional Support Status	Assessing for need for tube feeds/TPN by referring to subjects medical records	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Marc Ward, MD, Baylor Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gastroparesis; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Gastrectomy; Myotomy; Gastroscopy; Pyloromyotomy
• Other Study ID Numbers: 024-238

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No