NCT04869670

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
PROCEDURE	Gastric peroral endoscopic myotomy.	Under propofol anesthesia, EndoFLIP will be used to assess pyloric diameter and distensibility, prior to and after G-POEM, performed by an endoscopist skilled in this technique. After the procedure, the patient will be observed in the hospital for 2 days. Patients will undergo an upper GI series the next day to rule out perforation. If the patient develops a complication from the procedure, he or she will be managed per standard clinical practice by the treating (unblinded) endoscopist.
PROCEDURE	Sham Gastric peroral endoscopic myotomy.	Patients assigned to the sham procedure will be treated identically as above, except for the performance of the G-POEM. Endoscopy and EndoFLIP will be performed and sedation will be stopped when the upper endoscopy is completed. Since sham endoscopy is expected to take less time than G-POEM, the patient should remain in the endoscopy procedure room for a minimum of 30 minutes (including the time required to complete the upper endoscopy). After the procedure, the patient will be observed in the hospital for 2 days. All patients will undergo an upper GI series radiographic examination the next day to rule out perforation in order to maintain study blind.

Timeline

• Start date: 2023-07-12
• Primary completion: 2025-03-03
• Completion: 2025-03-03
• First posted: 2021-05-03
• Last updated: 2025-03-05

Locations

2 sites across 1 country: United States