Clinical Trial

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

Recruiting Phase 4
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-06; most recent amendment 2025-08-28.
Trial Details
NCT Number NCT07120295
Lead Sponsor University of Colorado, Denver
Collaborators: Dragonfly Endoscopy Inc
Conditions Bile Duct Adenocarcinoma, Bile Duct Carcinoma
Enrollment 75 participants
Start Date 2025-08-11
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2025-09-05