51
Participants
Start Date
August 1, 2023
Primary Completion Date
August 31, 2027
Study Completion Date
August 31, 2027
MAGUS placement
"An upper endoscopy will be performed with the use of fluoroscopy under general anaesthesia with orotracheal intubation. The delivery system will be placed over a guidewire, under fluoroscopy. The main steps are the following:~* Placement through the endoscope of a soft guidewire through the upper GI tract;~* Insertion of the MAGUS system on the guidewire;~* Advancement of the MAGUS system until proximal magnet reach the top of the septum;~* Release and placement of the proximal magnet at the bottom of the septum, pouch side;~* Meeting of the distal and proximal magnet on both sides of the septum, by pulling on the delivery system;~* Release of the distal magnet and activate the retractable wire;~* Insure that wire is not blocked and unblocked it if applicable.~Endoscopy and contrast injection will be performed before and after placement to ensure the correct positioning of the magnets."
RECRUITING
Hôpital Universitaire de Bruxelles - Hôpital Erasme, Brussels
Brussel Medical Device Center (BMDC)
UNKNOWN
Erasme University Hospital
OTHER