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.

EndoStim Patient Registry

GERD

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.

EndoStim LES Stimulation System

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

Safety will be assessed by incidence and severity of adverse events through 5 years of follow-up

Change from baseline in the following (while off PPI): % 24-hour esophageal pH<4.0, and number of reflux events >1 minute and > 5 minutes

Change from baseline in symptoms (measured by patient diary) and in quality of life (measured by SF-12)

Change from baseline in antisecretory medication use

Change from baseline on Structured GI Questionnaire responses

Change from baseline in sleep related quality of life (measured by Pittsburgh Sleep Quality Index)

Change from baseline in work productivity impairment (measured by Work Productivity and Activity Impairment Questionnaire)

Registry subjects whom have been implanted commercially with the EndoStim LES Stimulation System device.

Fundacion Favaloro

University Hospital Vienna

Aarhus University Hospital

SANA Klinikum Lichtenberg

Evangelisches Krankenhaus Castrop-Rauxel

Heilig Geist-Krankenhaus Köln

St. Marienstift Krankenhaus Friesoythe

Hospital zum Heiligen Geist Fritzlar

EndoStim Patient Registry

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?