SpyGlass AMEA Registry

Boston Scientific

Status

Completed

Conditions

Biliary Obstruction Due to Common Bile Duct Stone

Hemobilia

Periampullary Tumor

Biliary Stricture

Treatments

Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)

Device: SpyGlass DVS and SpyGlass Digital Simple (DS)

Study type

Observational

Funder types

Industry

Identifiers

NCT02281019

90947376

Details and patient eligibility

About

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.

Enrollment

526 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 or older.
Willing and able to provide written informed consent to participate in the study.
Willing and able to comply with the study procedures.
Indicated for ERCP and cholangioscopy or indicated for ERCP with suspected need for cholangioscopy.

Exclusion criteria

Endoscopic techniques are contraindicated.
ERCP is contraindicated
A medical condition that warrants the use of the device outside of the indication for use.
Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.