NCT01574339

Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD

An Investigation of the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (GERD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: EndoStim Inc. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The EndoStim LES Stimulation System is an investigational device intended to improve the LES pressure and restore Lower Esophageal Sphincter (LES) function in individuals suffering from Gastroesophageal Reflux Disease (GERD).

Detailed description

EndoStim has developed an investigational medical device specifically designed to deliver electrical stimulation to the LES and has completed two clinical feasibility studies using an external version of the EndoStim stimulation system in fifteen subjects. In these two short-term studies, electrical stimulation resulted in significant increases in LES pressure. This study will further evaluate the safety of the procedure and its feasibility for use in this group of patients.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DEVICE	EndoStim LES Stimulation System	The EndoStim LES Stimulation System comprises three components: an electrical stimulation lead, an implantable pulse generator (IPG) and an external programmer. The IPG and stimulation lead are to be implanted within the subject's body using conventional laparoscopy. The device programmer is to be used by the study investigator and/or a technical representative.

Timeline

• Start date: 2011-08-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2012-04-10
• Last updated: 2025-02-14

Locations

10 sites across 8 countries: Chile, Colombia, Hong Kong, India, Mexico, Netherlands, New Zealand, United Kingdom