NCT07526935

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Group 1	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	Group 2	Participants will undergo G-POEM and implantation of a GES. The stimulator will remain off for the first 6 months and will then be turned on for the following 6 months.
OTHER	Standard of Care	Participants who are part of the "control" group will not recieve the GES or the G-POEM. They will continue with standard of care treatment for GP, which involves dietary modifications and pharmacotherapies during the 12 months of the study.
PROCEDURE	G-POEM only	Participants will under G-POEM only if randomized to this group.

Timeline

• Start date: 2025-03-19
• Primary completion: 2028-12-30
• Completion: 2028-12-30
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study