3
Participants
Start Date
November 30, 2015
Primary Completion Date
November 30, 2017
Study Completion Date
November 30, 2018
SOC-directed biopsies using the SpyGlass System
The cholangioscopy procedure with the SpyGlass System is performed by a single operator with the SpyScope Access and Delivery Catheter positioned just below the operating channel of the duodenoscope. SpyBite Biopsy Forceps guided by the SpyScope Catheter are introduced and endoscopic-guided biopsy is taken at the level of the stricture. Target lesions will be identified under direct visualization using the SOC system, and 6-8 bites will be performed with the SpyBite forceps. Once SOC-directed biopsies are obtained, the SOC system will be withdrawn into the working channel of the duodenoscope and removed Patient will be contacted monthly to determine if they have undergone any additional procedures and to record potential adverse events.
Collaborators (1)
Thomas Jefferson University
OTHER
University of Pennsylvania
OTHER
University of Pittsburgh Medical Center
OTHER
Geisinger Clinic
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Temple University
OTHER