Trials / Completed
CompletedNCT02281019
SpyGlass AMEA Registry
Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 526 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2014-11-15
- Primary completion
- 2016-09-01
- Completion
- 2016-10-18
- First posted
- 2014-11-03
- Last updated
- 2019-07-10
Locations
20 sites across 10 countries: Australia, Hong Kong, India, Japan, Pakistan, Saudi Arabia, Singapore, South Africa, South Korea, Thailand
Source: ClinicalTrials.gov record NCT02281019. Inclusion in this directory is not an endorsement.