Magnetic Esophageal Sphincter implant is intended to reinforce Esophageal Sphincter function in the treatment of Gastroesophageal Reflux Disease (GERD)
The purpose of this feasibility study is to collect preliminary performance and safety information and develop procedural optimization for the Torax Medical Inc. Magnetic Esophageal Sphincter device (MES) in reinforcement of Esophageal Sphincter function to treat Gastroesophageal Reflux Disease (GERD). The information from this study will be used to support the design and conduct of an expanded clinical trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Implantable device, Magnetic Esophageal Sphincter
University of Southern California, Keck School of Medicine
Los Angeles, California, United States
Chapman Medical Center
Orange, California, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Policlinico San Donato
Milan, Italy
To Evaluate the Incidence of All Adverse Events at Various Time Points.
Time frame: 5 years
To Monitor the Improvement of GERD Symptoms.
Percentage of participants with a 50% or more reduction in total GERD-HRQL score is indicative of a substantial improvement in GERD symptoms
Time frame: 5 years
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Academisch Medisch Centrum (AMC)
Amsterdam, Netherlands