Prospective Multicenter Clinical Performance Study of a Single-use Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories
Summary
This study plans to enroll up to 75 research subject who have a biliary disorder such as bile duct stones or intermediate biliary strictures. The purpose of this research is to assess whether the Dragonfly™ Pancreaticobiliary Scope functioned as intended in combination with the commercially available accessories during your scheduled endoscopy procedure. This includes achieving stone fragmentation of difficult biliary stone(s) while obtaining adequate tissue specimens for analysis. There will also be a Product performance evaluation as rated by the endoscopist operating the DPS System and evaluation of ergonomics and usability.
Arms & interventions
- DeviceDragonfly™ Digital Pancreaticobiliary System
Dragonfly™ Digital Pancreaticobiliary System is indicated for use in the direct visualization of the biliary and pancreatic ducts for diagnostic and therapeutic interventions during endoscopic procedures. DPS is a single-use device that serves as an access and delivery catheter used with a proprietary DDC. The DDC is intended to control auto-illumination, and process images from the DPS for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.
Outcome measures
Primary
Stone Fragmentation- Clearing of Biliary Stones
Will evaluate the effectiveness of digital cholangioscopy (DC) in guiding fragmentation of difficult biliary stones. Will examine the efficacy of the intraductal lithotripsy procedure utilizing electrohydraulic lithotripsy in achieving biliary stone fragmentation and complete bile duct stone clearance among patients who have failed conventional stone extraction techniques. Stone fragmentation and complete ductal clearance will be assessed using descriptive statistics with interquartile range (IQR) for the number of procedures to achieve clearance at index or subsequent procedures. Ninety-five percent confidence intervals will be provided for descriptive statistics.
Time frame: Up to 6 months
Tissue Acquisition during endoscopy procedure
Will evaluate the ability of the DC to deliver tools to obtain adequate tissue samples (biopsies) to be analyzed for the presence or absence of disease, including cancer, infection, or other conditions in subjects with indeterminate strictures. Will use descriptive analysis with sensitivity, specificity, accuracy, median and IQR plus operating characteristics of visualization and sampling in those patients with indeterminate strictures. Will evaluate the diagnostic efficacy of the novel biopsy forceps in the context of indeterminate biliary strictures and provide robust evidence for clinical decision-making.
Time frame: Up to 6 months
Secondary
Total procedure time
Time frame: Up to 6 months
Product performance evaluation as rated by the endoscopist operating the DPS System
Time frame: Up to 6 months
DPS Functionality during Endoscopy Procedures
Time frame: Up to 6 months
Ergonomics
Time frame: Up to 6 months
Lithotripsy fragmentation time
Time frame: Up to 6 months
Product Performance
Time frame: Up to 6 months
Usability
Time frame: At the completion of the study
Visualization of biliary strictures
Time frame: Up to 6 months
Visualization of stone or stricture characteristics
Time frame: Up to 6 months
User satisfaction
Time frame: At the completion of the study
Passing of device to target area
Time frame: Up to 6 months
Work
Time frame: After each case
Bile duct stone recurrence rate
Time frame: At 6 months
Eligibility criteria
Study locations (1)
Universtiy of Colorado Hospital
Aurora, Colorado, 80045