Status:
COMPLETED
SpyGlass Direct Visualization System Clinical Registry in China
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Biliary Tract Diseases
Eligibility:
All Genders
18-85 years
Brief Summary
To document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System in China when used per standard of practice. Prospective, Post market, Multi-center, Non-ra...
Detailed Description
Patients who presenting with an indication for cholangioscopy or presenting with a possible indication for cholangioscopy to be determined during the ERCP procedure immediately preceding the SpyGlass ...
Eligibility Criteria
Inclusion
- Age above 18 and not above 85.
- 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 28 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT02287194
Start Date
November 28 2014
End Date
December 31 2017
Last Update
July 31 2018
Active Locations (1)
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1
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China