Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator

NCT07526935 | Active Not Recruiting FDA Device

• 1 other identifier: 024-238
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Subjects quality of life

  Baseline, 6 months, 12 months.

• Weight

  Baseline, 6 months, 12 months

• BMI

  Baseline, 6 months, 12 months

• Nutritional Support Status

  Baseline, 6 months, 12 months

• Gastroparesis-related hospitalizations

  12 month follow-up

Study Arms (4)

Control group

ACTIVE COMPARATOR

GES off + Upper Endoscopy

Device: GES + Upper endoscopy

GES only

ACTIVE COMPARATOR

GES on + Upper Endoscopy

Device: GES on + Upper endscopy

G-POEM only

ACTIVE COMPARATOR

GES off + GPOEM

Procedure: GES off + G-POEM

Combination G-POEM and GES

ACTIVE COMPARATOR

GES on + GPOEM

Procedure: GES on + G-POEM

Interventions

GES + Upper endoscopy DEVICE

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.

Control group

GES on + Upper endscopy DEVICE

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.

GES only

GES off + G-POEM PROCEDURE

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.

G-POEM only

GES on + G-POEM PROCEDURE

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.

Combination G-POEM and GES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Gastroscopy; Pyloromyotomy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Gastrectomy; Myotomy

Study Officials

• Marc Ward, MD

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: March 19, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)