Actively Recruiting
Study of Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories
Led by University of Colorado, Denver · Updated on 2025-09-05
75
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
D
Dragonfly Endoscopy Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated consent form
- Adult patients 21 years old or older
- Patients needing ERCP with cholangioscopy for indeterminate biliary stricture or failed biliary stone extraction
- Willing and able to follow study procedures and comply with follow-up
You will not qualify if you...
- Pregnancy or lactation
- Surgically or physiologically altered gastrointestinal anatomy preventing duodenoscope advancement for biliary cannulation
- Use of anti-coagulants or anti-platelet medications that cannot be stopped before the procedure, except aspirin 81 mg
- Uncorrectable coagulopathy (INR > 1.8) or thrombocytopenia (platelets < 50,000) contraindicating biopsy or lithotripsy
- Active suppurative cholangitis with purulent drainage seen during papilla visualization
- Not a candidate for anesthesia needed for ERCP
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Universtiy of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
R
Rodolfo Hernandez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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