Clinical trial · Observational
SpyGlass AMEA Registry
Clinical Registry of Cholangioscopy Using the SpyGlass™ Direct Visualization System (DVS) Throughout the AMEA (Asia, Middle-East, Africa) Region
NCT02281019CI-TRIAL-00039416completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Obstruction Due to Common Bile Duct Stone | — | UNRESOLVED | — |
| Biliary Stricture | — | UNRESOLVED | — |
| Hemobilia | — | UNRESOLVED | — |
| Periampullary Tumor | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERCP (Endoscopic Retrograde Cholangiopancreatography) | Procedure | — | UNRESOLVED |
| SpyGlass DVS and SpyGlass Digital Simple (DS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Indeterminate strictures or undefined filling defects
- interventionNames
- Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)
- Device: SpyGlass DVS and SpyGlass Digital Simple (DS)
- label
- Biliary stone cases
- interventionNames
- Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)
- Device: SpyGlass DVS and SpyGlass Digital Simple (DS)
- label
- Other indications
- interventionNames
- Procedure: ERCP (Endoscopic Retrograde Cholangiopancreatography)
- Device: SpyGlass DVS and SpyGlass Digital Simple (DS)
Primary outcomes (3)
- measure
- Procedural success for indeterminate strictures or undefined filling defects
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMaydeo AP, Rerknimitr R, Lau JY, Aljebreen A, Niaz SK, Itoi T, Ang TL, Reichenberger J, Seo DW, Ramchandani MK, Devereaux BM, Lee JK, Goenka MK, Sud R, Nguyen NQ, Kochhar R, Peetermans J, Goswamy PG, Rousseau M, Bhandari SP, Angsuwatcharakon P, Tang RSY, Teoh AYB, Almadi M, Lee YN, Moon JH; SpyGlass AMEA Registry Group. Cholangioscopy-guided lithotripsy for difficult bile duct stone clearance in a single session of ERCP: results from a large multinational registry demonstrate high success rates. Endoscopy. 2019 Oct;51(10):922-929. doi: 10.1055/a-0942-9336. Epub 2019 Jun 27. PMID 31250408