SpyGlass AMEA Registry

Summary

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.

Conditions

• Biliary Stricture
• Biliary Obstruction Due to Common Bile Duct Stone
• Periampullary Tumor
• Hemobilia

Interventions

PROCEDURE

ERCP (Endoscopic Retrograde Cholangiopancreatography)

ERCP procedure will be performed to visualize bile ducts.

DEVICE

SpyGlass DVS and SpyGlass Digital Simple (DS)

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

Sponsors & Collaborators

• Boston Scientific Corporation

  lead INDUSTRY

Principal Investigators

• Benedict Devereaux · Royal Brisbane and Women's Hospital

• James Lau · Prince of Wales Hospital

• Randhir Sud · Institute of Digestive & Hepatobiliary Sciences

• Saad Niaz · Civil Hospital Karachi

• Abdulrahman Aljebreen · King Khalid University Hospital

• Ang Tiing Leong · Changi General Hospital Pte Ltd.

• Jorg Reichenberger · Netcare Unitas Hospital

• Jong Moon · Soon Chun Hyang University

• Rungsun Rerknimitr · King Chulalongkorn Memorial Hospital

• Ichiro Yasuda · Teikyo University Mizonokuchi Hospital

• Arthur J. Kaffes · Royal Prince Alfred Hospital, Sydney, Australia

• Nam Q. Nguyen · Royal Adelaide Hospital

• Amit Maydeo · Baldota Institute of Digestive Sciences

• Mohan Ramchandani · Asian Institute of Gastroenterology

• Mahesh Goenka · Apollo Gleneagles Hospital

• Professor R. Kochhar · Postgraduate Institute of Medical Education & Research

• Takao Itoi · Tokyo Medical University

• Masayuki Kitano · Kinki University School of Medicine

• Jong K. Lee · Samsung Medical Center

• Dongwan Seo · Asan Medical Center

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-15

Primary Completion

2016-09-30

Completion

2016-10-18

Countries

• Australia
• Hong Kong
• India
• Japan
• Pakistan
• Saudi Arabia
• Singapore
• South Africa
• South Korea
• Thailand

Study Locations