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SpyGlass™ DS

Direct Visualization System

SpyGlass DS Case Studies

SpyGlass DS Clinical Data

SpyGlass DS for Stone Management

SpyGlass DS Ordering Information

Clinical Data Highlights – First Generation SpyGlass Direct Visualization System

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. 

Clinical Registry Details

Yang Chen, MD, et al, GIE , Vol. 74, 2011
Clinical Registry Details

Key Resources

Visit EndoSuite Learning Center Indications, Safety, and Warnings for SpyGlass DS Digital Controller Indications, Safety, and Warnings for SpyScope™ DS Indications, Safety, and Warnings for SpyBite™ Single-Use Biopsy Forceps
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Key Results

Clinical Registry results infographic
 
Procedural success for SOC-directed stone therapy was defined as visualization of biliary stones and initiation of stone fragmentation and removal.

Indeterminate Stricture Diagnosis:

  • 26 patients, Peter Draganov, MD, et al, GIE, Vol. 75(2), 2012
  • Key Results: Demonstrated 76.5% sensitivity using SpyBite™ Forceps performing cholangioscopy with the SpyGlass System vs 29.4% sensitivity using blind biopsy and 5.9% sensitivity using brushings.

Stone Management:

  • 108 patients, Takao Itoi, MD, et al, Digestive Endoscopy, Vol. 22, S1,2010
  • Key Results: 24% of patients had residual stones missed on standard ERCP without cholangioscopy.
  • 64 patients, Amit Maydeo, MD, et al, GIE, Vol. 74(6), 2011
  • Key Results: Demonstrated 83.3% stone clearance in a single ERCP session
  • Inclusion criteria: Difficult CBD stones not amenable to mechanical lithotripsy and/or balloon sphincteroplasty.

Pre-Clinical & Clinical Registry Results: SpyGlass System (First Generation)

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
 

Evaluation of Clinical Utility of SpyGlass System (First Generation)

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
 

Indeterminate Stricture Diagnosis Using SpyGlass System (First Generation)

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
 

Stone Management Using SpyGlass System (First Generation)

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
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