EndoStim Patient Registry (RESTORE)

EndoStim

Status: Terminated

Conditions: GERD

Treatments: Device: EndoStim LES Stimulation System

Study type: Observational

Funder types: Industry

Identifiers

NCT02441400

CS500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject meets therapy indications
2. Subject signs informed consent
3. 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

Trial design

350 participants in 1 patient group

EndoStim LES Stimulation System implant.

Description:

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

Treatment:

Device: EndoStim LES Stimulation System