Clinical Registry using the SpyGlassâ?¢ Direct Visualization System to document indications for cholangioscopy and clinical utility throughout the Asia, Middle-East, Africa region when used per standard of practice
Phase 4
Completed
- Conditions
- Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhereHealth Condition 2: null- Patients with very different distribution of bile duct diseases, such as biliary strictures, biliary obstructions due to common bile duct stone, periampullary tumors, and Hemobilia.
- Registration Number
- CTRI/2014/11/005173
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
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
1.Endoscopic techniques are contraindicated.
2.ERCP is contraindicated
3.A medical condition that warrants the use of the device outside of the indication for use.
4.Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Procedural Success <br/ ><br>1.Indeterminate strictures: 1) ability to visualize stricture or defect 2) ability to provide visual impression of malignancy 3) when applicable, ability to obtain SpyBite biopsy adequate for histology <br/ ><br>2.Biliary stones cases: 1) ability to visualize stones 2) ability to successfully initiate stone fragmentation 3) ability to achieve stone clearance in one or more SpyGlass procedures. <br/ ><br>3.Other Indications: ability to establish diagnosis and /or complete therapy <br/ ><br>Timepoint: Procedure
- Secondary Outcome Measures
Name Time Method