UAS-RBS: a Safety Study

NACompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

March 27, 2018

Primary Completion Date

March 31, 2021

Study Completion Date

March 31, 2021

Conditions
Refractory Benign Strictures
Interventions
DEVICE

Esophageal stent implantation

"An upper endoscopy will be performed with the use of fluoroscopy. Depending on the size of the stricture a dilation can be performed prior to the stent deployment. Otherwise, the stent will be deployed over a guidewire, under fluoroscopy.~After, the gastroscopy will go through the esophagus to check for the stent deployment, or any complications.~An injection of contrast agent will be done to be sure of the correct positioning and that no complications was happened.~The patient will be kept overnight, with liquid food for 3 days and under PPI until one month after the stent placement."

DEVICE

Stent removal

Six months after implantation, the removal of the stent will be performed. Patient will undergo a first endoscopy under general anesthesia for the placement of a FCSEMS. Then, depending on the importance of the hyperplasia, removal of both stents, under general anesthesia, will be done after 7 to 10 days.

Trial Locations (1)

1070

CUB Hopital erasme, Anderlecht

All Listed Sponsors
lead

Erasme University Hospital

OTHER

NCT03652285 - UAS-RBS: a Safety Study | Biotech Hunter | Biotech Hunter