NCT02514616

Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter (GERD)

Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter: a Multicenter, Randomized, Double-blind, Sham-controlled Parallel-group Trial Evaluating Short Term Efficacy of EndoStim Device on GERD

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The investigational device that will be used in this trial is the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System. The purpose of this trial is to evaluate the safety and the effectiveness of electrical stimulation therapy (EST) on the lower esophageal sphincter (LES) in the treatment of subjects with gastroesophageal reflux disease (GERD). The study population will consist of subjects diagnosed with pathological GERD as defined by abnormal pH and who complain of heartburn, regurgitation or both for \> 6 months, on a daily PPI use.

Detailed description

Study Design: Multicenter, randomized, double-blind, sham-controlled study. All subjects undergo screening and baseline visits, followed by system implantation, and randomization after 2 weeks to either a treatment Group (stimulation) or Control Group (delayed stimulation). Randomized subjects complete a 10-week, double-blind phase. At the 14-week visit, subjects are unblinded, control group subjects begin receiving stimulation, and all subjects are followed for an additional 9-month open-label treatment phase. Subjects continue receiving stimulation for an extended follow-up phase involving annual visits through 5 years. Study Visits: Screening and baseline visits. Laparoscopic implantable pulse generator (IPG) and lead implant procedure. Post-implant follow-up office visits at 2 weeks/randomization, 6, 10, 14, 24 and 48 weeks, followed by annual visits through 5 years. Sample Size and Scope: Forty-six subjects will be implanted and followed to 12 months after stimulation treatment at 3 investigational sites.

Conditions

• GERD

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-08-04
• Last updated: 2015-11-20

Locations

2 sites across 2 countries: Belgium, France