NCT02441400

EndoStim Patient Registry

EndoStim Patient Registry-LES Stimulation System for the Treatment of GERD

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 350 (actual)
• Sponsor: EndoStim Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

To provide a research tool enabling physicians to monitor long term clinical outcomes for patients undergoing gastroesophageal reflux disease (GERD) treatment with EndoStim LES Stimulation System.

Detailed description

The EndoStim Patient Registry provides a framework for data collection on patients with GERD treated with the EndoStim LES Stimulation System. The primary objective is to provide a tool for participating physician investigators to collect and analyze outcomes data related to the use of the EndoStim LES Stimulation System. This is a prospective, multi-center patient Registry. Sites may choose to also retrospectively enroll previously treated patients (after obtaining informed consent) and enter retrospective data into case report forms paper or on-line.

Conditions

• GERD

Interventions

Type	Name	Description
DEVICE	EndoStim LES Stimulation System

Timeline

• Start date: 2013-05-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2015-05-12
• Last updated: 2024-10-15

Locations

30 sites across 7 countries: Argentina, Austria, Denmark, Germany, Mexico, Netherlands, United Kingdom