EndoStim Patient Registry

Study Overview
=================
Brief 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.

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

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Device: EndoStim LES Stimulation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject meets therapy indications Subject signs informed consent Subject has a planned EndoStim LES Stimulation System implant (prospective) OR subject has already had EndoStim LES Stimulation System implant (retrospective) Exclusion Criteria: 1. Subject meets therapy contraindications

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EndoStim LES Stimulation System implant.<br>Registry subjects whom have been implanted commercially with the EndoStim LES Stimulation System device. | Device: EndoStim LES Stimulation System<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events | Safety will be assessed by incidence and severity of adverse events through 5 years of follow-up | 5 years post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in GERD-HRQL | Change from baseline GERD-HRQL | Various timepoints | 
| Comparison of pH values | 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 | Various timepoints | 
| Comparison of symptoms and quality of life | Change from baseline in symptoms (measured by patient diary) and in quality of life (measured by SF-12) | Various timepoints | 
| Change in antisecretory medication use | Change from baseline in antisecretory medication use | Various timepoints | 
| Change in Structured GI Questionnaire responses (vs. baseline) | Change from baseline on Structured GI Questionnaire responses | Various timepoints | 
| Change in sleep related quality of life | Change from baseline in sleep related quality of life (measured by Pittsburgh Sleep Quality Index) | Various timepoints | 
| Change in work productivity impairment | Change from baseline in work productivity impairment (measured by Work Productivity and Activity Impairment Questionnaire) | Various timepoints | 
| Change in Reflux Disease Questionnaire (RDQ) scores | Change from baseline in RDQ scores | Various timepoints | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, LES Pressure, Electrical Stimulation