Endoscopic Fundoplication With MUSE System

RecruitingOBSERVATIONAL
Enrollment

80

Participants

Timeline

Start Date

September 16, 2015

Primary Completion Date

September 16, 2021

Study Completion Date

September 30, 2026

Conditions
Gastro-esophageal RefluxEndoscopic Fundoplication
Interventions
DEVICE

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."

Trial Locations (1)

20132

RECRUITING

Pier Alberto Testoni, Milan

All Listed Sponsors
lead

IRCCS San Raffaele

OTHER