Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 30, 2023

Primary Completion Date

October 31, 2027

Study Completion Date

February 29, 2028

Conditions
HypoglycemiaGastric Outlet ObstructionSteatohepatitisParenteral SupportGastric Bypass
Interventions
DEVICE

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.

Trial Locations (2)

9000

RECRUITING

University Hospital, Ghent, Ghent

Unknown

RECRUITING

AZ Sint-Jan Brugge, Bruges

All Listed Sponsors
lead

University Hospital, Ghent

OTHER