161
Participants
Start Date
May 31, 2016
Primary Completion Date
October 31, 2019
Study Completion Date
October 31, 2019
Laparoscopic implantation surgery
Laparoscopic surgery to implant the pulse generator and bipolar lead.
EndoStim stimulation for first six months of study
Lower esophageal stimulation
EndoStim stimulation from Month 6 thru end of study
Lower esophageal stimulation
Sham EndoStim stimulation for first six months of study
"EndoStim device remains off (no stimulation delivered)"
Cornell University Weill Medical College, New York
Columbia University Medical Center, New York
Allegheny Health Network Research Institute, Pittsburgh
Virginia Commonwealth University, Richmond
University of North Carolina, Chapel Hill
Carolinas HealthCare System, Charlotte
University of South Florida, Tampa
Vanderbilt University Medical Center, Nashville
The Ohio State University Medical Center, Columbus
The MetroHealth System, Cleveland
Baylor Scott & White Research Institute, Round Rock
Institute of Esophageal and Reflux Surgery, Englewood
St. Joseph's Hospital and Medical Center, Phoenix
HonorHealth Research Institute, Scottsdale
University of Southern California (USC), Los Angeles
Stanford Center for Clinical Research, Stanford
Oregon Clinic, Portland
Oregon Health Science University, Portland
Universitaire Ziekenhuizen Leuven, Leuven
Clinical Trial Center Maastricht, Maastricht
University College London, London
Lead Sponsor
EndoStim Inc.
INDUSTRY