NCT04349670

Safety and Efficacy of GPOEM in the Treatment of Gastroparesis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The purpose of this study is to assess the clinical efficacy and safety in the treatment of gastroparesis.

Detailed description

After being informed about the data collected, all the patients affected with gastroparesis undergoing Gastric Per-Oral Endoscopic Myotomy (GPOEM) will be included in the observational protocol. Data concerning pre-operative symptoms and results of the imaging studies will be recorded together with operative time and operative complications. Patients will undergo periodical clinical consults and gastric emptying scintigraphy to assess the improvement in the symptoms and gastric motility.

Conditions

• Gastroparesis
• Gastroparesis Postoperative
• Gastroparesis With Diabetes Mellitus

Interventions

Type	Name	Description
PROCEDURE	GPOEM - gastric per-oral endoscopic myotomy	Endoscopic section of the pyloric muscle with submucosal tunnel technique.

Timeline

• Start date: 2020-06-01
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2020-04-16
• Last updated: 2020-05-29

Locations

1 site across 1 country: Italy