60
Participants
Start Date
September 2, 2022
Primary Completion Date
August 28, 2026
Study Completion Date
February 1, 2027
EndoRotor® System (Interscope, Inc., Northbridge, MA USA),
The EndoRotor System is intended for use in endoscopic procedures to resect and remove necrotic debris during DEN for WON. DEN with the EndoRotor System (study device) is considered to be standard of care therapy for patients with WON and not investigational.
Conventional endoscopic devices (according to standards of care)
Endoscopic devices used to perform conventional DEN will be chosen according to standard of care and Investigator preference.
Thomas Jefferson University Hospital, Philadelphia
University of Alabama Medical Center, Birmingham
California Pacific Medical Center, San Francisco
Copenhagen University Hospital, Hvidovre
Evangelical Hospital, Düsseldorf
University of Frankfurt, Frankfurt
Humanitas Reserach Hospital & Humanitas University, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma
Amsterdam University Medical Center, Amsterdam
St. Antonius Hospital, Nieuwegein
Central Manchester University Hospital, Manchester
Charlotte van Veldhuisen, Amsterdam
Lead Sponsor
Collaborators (1)
Interscope, Inc.
INDUSTRY
Erasmus Medical Center
OTHER