Feasibility of a Single-operator Peroral Cholangiopancreatioscopy System (SpyGlass)

Withdrawn before enrolling

Conditions studied: Bile Duct Strictures, Common Bile Duct Stones

In brief

Cholangioscopy, or direct visualization of the bile ducts was first documented in the late 1970s and has made many advances over the last few decades. The advent of mother-baby scopes allowed for both diagnostic and therapeutic procedures, though the early scopes were often fragile, and cumbersome due to the need for two endoscopists. Ultraslim endoscopes later became popular as a method to digitally view the bile ducts, however, often needed guide-wire or balloon-assistance to allow for cannulation. Other disadvantages of these systems included limited steerability, and poor irrigation capabilities. The advent of Spyglass, a single-operator peroral cholangioscopy method allowed for a fiberoptic, catheter-based system that could be easily used for diagnostic and therapeutic purposes in the biliary system. However, image quality was often lacking due to the fiberoptic technology. The new digital Spyglass system rectifies this inadequacy by introducing a digital sensor for better image quality, which will allow for better visualization and diagnosis of indeterminate strictures. Furthermore, modification of the scope platform allows for efficient use, reliable directionality of the scope tip, and improved ease of passage of accessories during therapeutic procedures such clearing stones or stent placement.

Key facts

Study ID

NCT02776709

Run by

Northwestern University

People needed

0

Starts

2015-07-01

Expected to finish

2018-05-01

Last updated by the study team

2020-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All patients referred for the evaluation of indeterminate strictures or removal of difficult stones.

You may not qualify if…

• All patients who are unable or unwilling to give consent will not be included in this study

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• University of Colorado, Denver — Denver, Colorado, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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