Since the launch of the first generation SpyGlass Direct Visualization System in 2007, more than 50,000 procedures have been performed and over 150 articles published - further documenting its clinical significance as a valuable extension of the ERCP procedure.
Yang Chen, MD, et al, GIE , Vol. 74, 2011
Procedural success for SOC-directed stone therapy was defined as visualization of biliary stones and initiation of stone fragmentation and removal.
| Key Data | Journal Article | Authors | Study Type | Publication |
|---|---|---|---|---|
| The SpyGlass System allows access and biopsy targeting | Pre-clinical characterization of the SpyGlass™ peroral cholangiopancreatoscopy system for direct access, visualization and biopsy | Yang Chen et al |
Lab simulation & observational investigation, single user |
GIE, Vol. 65, No. 2: February 2007 |
| Peroral Cholangioscopy (POC) identified stones missed by ERCP in 29% pts. | Peroral Cholangioscopy (POC) Using a Disposable Steerable Single Operator Catheter for Biliary Stone Therapy and Assessment of Indeterminate Strictures - A Multi-Center Experience Using SpyGlass | Yang Chen et al | Abstract | DDW® 2008 Abstract |
• 297 patients • 64% altered patient management • 92% stone success • 66% sensitivity |
Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos) |
Yang Chen et al |
Prospective clinical cohort study |
GIE, Vol. 74, Issue 4, October 2011 |
| Key Data | Journal Article | Authors | Study Type | Publication |
|---|---|---|---|---|
• 75 patients • 14.2 min mean SpyGlass System visualization time • 5 min mean setup time |
Pre-clinical characterization of the SpyGlass™ peroral cholangiopancreatoscopy system for direct access, visualization and biopsy | Peter Draganov et al | Prospective cohort study |
GIE, Vol. 73, Issue 5, May 2011 |
| Key Data | Journal Article | Authors | Study Type | Publication |
|---|---|---|---|---|
• 26 patients • 76.5% sensitivity SpyBite™ Forceps vs.29.4% blind biopsy & 5.9% brushings |
Diagnostic accuracy of conventional and cholangioscopy-guided sampling of indeterminate biliary lesions at the time of ERCP: a prospective, long-term follow-up study | Peter Draganov et al | Prospective, long-term follow-up, paired design cohort study | GIE, Vol. 75 (2);February 2012 |
• 52 patients • 88% sensitivity |
SpyGlass™ single-operator peroral cholangioscopy in the evaluation of indeterminate biliary lesions: a single-center, prospective, cohort study | Raffaele Manta et al | Single-center, prospective, cohort study | Surgical Endoscopy, 2013: 27 |
• 36 patients • 95% cholangioscopic impression for malignancy • 82% SpyBite Forceps differentiating intent-to-treat |
Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study | Mohan Ramchandani et al | Prospective, single-arm,single-center study | GIE, Vol. 79 (6),June 2014 |
| Key Data | Journal Article | Authors | Study Type | Publication |
|---|---|---|---|---|
• 108 patients • 24% residual stones missed on standard ERCP • Risk factors: large bile duct, juxtapapillary diverticulum, use of ML or EHL |
Evaluation of Residual Bile Duct Stones by Peroral Cholangioscopy in Comparison with Balloon Cholangioscopy | Takao Itoi et al | Retrospective | GIE, Vol. 74(6), December 2011 |
• 64 patients • 83.3% single session clearance • Inclusion criteria: Difficult bile duct stones not amenable to treatment by mechanical lithotripsy and/or balloon sphincteroplasty. |
Single-operator cholangioscopy-guided laser lithotripsy in patients with difficult biliary and pancreatic ductal stones (with videos) | Amit Maydeo et al | Prospective | Surgical Endoscopy, 2013: 27 |
• 13 patients • 76.9% complete clearance • Inclusion criteria: Cystic duct stones |
Single-operator cholangioscopy for the extraction of cystic duct stones (with video) | Paul Sepe et al | Retrospective | GIE, Vol. 75(1), January 2012 |
