CompletedNot Applicable

SpyGlass AMEA Registry

Australia, Hong Kong, India526 participantsStarted 2014-11-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Procedural success for indeterminate strictures or undefined filling defects

Timeframe: Procedure - the average expected duration of the procedure is 1.5 hours

Procedural success for biliary stone cases

Timeframe: Procedure - the average expected duration of the procedure is 1.5 hours

Procedural success for other indications

Timeframe: Procedure - the average expected duration of the procedure is 1.5 hours

Trial details

NCT IDNCT02281019

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Biliary Stricture trials