Status:
COMPLETED
SpyGlass AMEA Registry
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Biliary Stricture
Biliary Obstruction Due to Common Bile Duct Stone
Eligibility:
All Genders
18+ years
Brief 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 wh...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 18 2016
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT02281019
Start Date
November 15 2014
End Date
October 18 2016
Last Update
July 10 2019
Active Locations (20)
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1
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
2
Royal Adelaide Hospital
Adelaide, Australia
3
Royal Prince Alfred Hospital
Newtown, Australia
4
Prince of Wales Hospital
Shatin, Hong Kong