NCT02514616 - Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter (GERD) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions

GERD

Interventions

PROCEDURE

Laparoscopic IPG and lead implant procedure

EST placement

DEVICE

Active Electric Stimulation Therapy

Device programming by the technician to deliver the EST system active (Treatment group) or no stimulation (Control group) for the following 12 weeks, at the 2 weeks visit.

DEVICE

Delayed Electric Stimulation Therapy

Device programming by the technician to deliver the EST system no stimulation for the following 12 weeks at the 2 weeks visit. Active Electric Stimulation Therapy will be programmed at the 14 weeks visit.

Trial Locations (2)

1070

Gastroenterology Department, Erasme University Hospital, Brussels

69437

Hôpital Edouard Herriot, Service d'Explorations Fonctionnelles Digestives, Pavillons H et L, 5 Place d'Arsonval, Lyon