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Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator

NCT07526935 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-30

No results posted yet for this study

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

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Marc Ward, MD · Baylor Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-19
Primary Completion
2028-12-30
Completion
2028-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07526935 on ClinicalTrials.gov