20
Participants
Start Date
January 30, 2023
Primary Completion Date
October 31, 2027
Study Completion Date
February 29, 2028
The Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System
EUS-guided gastro-gastrostomy using the Hot Axios device: Using a therapeutic endoscopic ultrasound endoscope with a working channel of 3.7mm and under fluoroscopic control, the excluded stomach will be identified and punctured with a 19G needle. Contrast injection will confirm the good position of the needle in the excluded stomach. If needed, the excluded stomach will be filled with blue-stained aqua (5% indigocarmine) until a sufficient distension is obtained for placement of the lumen-apposing metal stent. A lumen-apposing metal stent with a diameter of 20mm will be used according to the manufacterers' instructions to create a gastrogastrostomy. Position will be checked with fluoroscopy.
RECRUITING
University Hospital, Ghent, Ghent
RECRUITING
AZ Sint-Jan Brugge, Bruges
University Hospital, Ghent
OTHER