Gastroesophageal Reflux Disease (GERD) Clinical Trial
Official title:
Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)
The study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling
system for the treatment of GERD.
The system allows the operator to staple the stomach to the esophagus,in order to restore
the gastroesophageal flap valve. The effect of the stapling is similar to a common operation
for GERD (partial fundoplication) but is done through the mouth, and incision into the
abdomen is not needed.
The hypothesis of the study is that the treatment will be effective in improving GERD
related quality of life by 50% or more in the majority of the subjects, and that the
procedure will be as safe as surgery.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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