80
Participants
Start Date
September 16, 2015
Primary Completion Date
September 16, 2021
Study Completion Date
September 30, 2026
Endoscopic fundoplication
"Endoscopic fundoplication is a less invasive alternative to the traditional surgical fundoplication.~The MUSE device is similar to an endoscope, so the whole procedure can be done by a single operator. The device is composed of a shaft with a distal rigid part which is placed in the esophagus 3 cm proximal to the esophago-gastric junction containing a cartridge holding five B-shaped titanium surgical Staples and a tip which is retroflexed and contains an ultrasonic transducer which defines the correct tissue thickness for stapling the fundus against the esophagus. The device must be extracted to be reloaded with 5 more staples at a time for creation of a 180° anterior fundoplication."
RECRUITING
Pier Alberto Testoni, Milan
IRCCS San Raffaele
OTHER