Condition: Gastroesophageal Reflux Disease (GERD) · Reflux, Gastroesophageal · Gastroesophageal Reflux · Sponsor: EndoStim Inc.
The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled study. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for six months followed by an additional open-label phase in which all subjects will receive electrical stimulation. Subjects continue on stimulation treatment in an extended open-label follow-up phase through 5 years post-stimulation.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
| St. Joseph's Hospital and Medical Center | Phoenix, Arizona, United States | — |
| HonorHealth Research Institute | Scottsdale, Arizona, United States | — |
| University of Southern California (USC) | Los Angeles, California, United States | — |
| Stanford Center for Clinical Research | Stanford, California, United States | — |
| Institute of Esophageal and Reflux Surgery | Englewood, Colorado, United States | — |
| University of South Florida | Tampa, Florida, United States | — |
| Cornell University Weill Medical College | New York, New York, United States | — |
| Columbia University Medical Center | New York, New York, United States | — |
| University of North Carolina | Chapel Hill, North Carolina, United States | — |
| Carolinas HealthCare System | Charlotte, North Carolina, United States | — |
| The MetroHealth System | Cleveland, Ohio, United States | — |
| The Ohio State University Medical Center | Columbus, Ohio, United States | — |
+ 9 more locations — full list on the registry record.
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