Symptoms and General Pathology

All Conditions

Calculi

Constriction, Pathologic

Hemobilia

Hemorrhage

ERCP procedure will be performed to visualize bile ducts.

ERCP (Endoscopic Retrograde Cholangiopancreatography)

Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed

SpyGlass DVS and SpyGlass Digital Simple (DS)

Benedict Devereaux

James Lau

Randhir Sud

Saad Niaz

Abdulrahman Aljebreen

Ang Tiing Leong

Jorg Reichenberger

Jong Moon

Rungsun Rerknimitr

Ichiro Yasuda

Arthur J. Kaffes

Nam Q. Nguyen

Amit Maydeo

Mohan Ramchandani

Mahesh Goenka

Professor R. Kochhar

Takao Itoi

Masayuki Kitano

Jong K. Lee

Dongwan Seo

The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of practice.

SpyGlass AMEA Registry

Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region

For indeterminate strictures or undefined filling defects cases procedural success is defined as 1) ability to visualize stricture or defect, and 2) ability to provide visual impression of malignancy, and 3) when applicable, ability to obtain SpyBite biopsy adequate for histology

For biliary stone cases procedural success is defined as 1) ability to visualize the stone(s), and 2) ability to successfully initiate stone fragmentation, and 3) ability to achieve stone clearance in one or more SpyGlass procedures.

For other indications procedural success is defined as ability to establish diagnosis and /or complete therapy in the following categories: 1) pre-operative assessment of extent of peri-ampullary and biliary tumors, 2) selective guidewire placement, 3) assessment of unexplained hemobilia, 4) assessment of portal biliopathy, 5) assessment of intraductal biliary ablation therapy, 6) extraction of migrated stents, or 7) other.

Evaluation of serious adverse events (SAEs) related to the SpyGlass devices and/or the SpyGlass procedure from enrollment through the 72 Hour Post Procedure Follow-up Visit.

Assessment Detail:

Endpoint determined for all patients in whom SpyBite biopsy was taken and observed image features were reported.

Observed image features include the following categories: None, Growth, Stricture, Hyperplasia, Ulceration, Mass, Dilated tortuous vessels, Papillary or villous projections, Intraductal nodules, Mucus.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
SpyGlass AMEA Registry	NCT02281019	Biliary Strictu... Biliary Obstruc... Periampullary T... Hemobilia	ERCP (Endoscopi... SpyGlass DVS an...	18 Years -	Boston Scientific Corporation
SpyGlass AMEA Registry	NCT02281019	Biliary Strictu... Biliary Obstruc... Periampullary T... Hemobilia	ERCP (Endoscopi... SpyGlass DVS an...	18 Years -	Boston Scientific Corporation

Spots Global Cancer Trial Database for biliary obstruction due to common bile duct stone