Study of Dragonfly™ Digital Pancreaticobiliary System for Bile Duct Conditions
This study is testing a new medical device called the Dragonfly™ Digital Pancreaticobiliary System (DPS). This device helps doctors see inside your bile and pancreatic ducts during an endoscopy procedure. The study aims to see if the Dragonfly™ DPS works as intended with other tools to break up difficult bile duct stones and collect tissue samples for diagnosis. It's for adults aged 21 and older who need an endoscopy for conditions like bile duct stones that couldn't be removed with standard methods, or for unclear blockages in the bile duct. The study plans to include up to 75 participants. Success will be measured by how well the device breaks up stones and collects tissue within 6 months.
- Study design
- This is an interventional study planning to enroll up to 75 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would undergo an endoscopic retrograde cholangiopancreatography (ERCP) procedure where the Dragonfly™ Digital Pancreaticobiliary System is used. The study will assess stone fragmentation and tissue acquisition during this procedure, with follow-up for up to 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 6 months to assess stone fragmentation and tissue acquisition.
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Study of Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Stone Fragmentation- Clearing of Biliary StonesUp to 6 months
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.
- Tissue Acquisition during endoscopy procedureUp to 6 months
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.