GERD Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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