RecruitingPhase 4NCT07120295

Study of Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories

Prospective Multicenter Clinical Performance Study of a Single-use Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories


Sponsor

University of Colorado, Denver

Enrollment

75 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new large-channel digital scope (a thin camera inserted through the mouth) for two specific uses during ERCP procedures: examining bile duct narrowings of unknown cause, and removing bile duct stones that couldn't be cleared with standard techniques. This new device may offer better visualization and tools for these challenging situations. **You may be eligible if...** - You are 21 or older and need an ERCP procedure - You have either: an unexplained bile duct narrowing (stricture) that needs further investigation, OR a bile duct stone that could not be removed with standard techniques - You are willing and able to follow study procedures and attend follow-up visits **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a condition that makes ERCP unsafe - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Universtiy of Colorado Hospital

Aurora, Colorado, United States

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NCT07120295


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