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

Purpose

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

  • Bile Duct Adenocarcinoma
  • Bile Duct Carcinoma

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Provision to sign and date the consent form; 2. Adult patients ≥ 21 years old; 3. Any patient who is required to undergo endoscopic retrograde cholangiopancreatography (ERCP) procedure with the clinical need to perform cholangioscopy for: 1. Indeterminate biliary stricture, or 2. Failed biliary stone extraction with conventional techniques. 4. Willing and able to follow study procedures and comply with study follow-up.

Exclusion Criteria

  1. Pregnancy or lactation; 2. Surgically or physiologically altered GI anatomy that precludes advancement of the duodenoscope for biliary cannulation; 3. Patients on anti-coagulants and anti-platelet medications that cannot be withheld pre-procedure, except for aspirin, 81mg; 4. Coagulopathy (INR > 1.8) or thrombocytopenia (Platelets < 50,000) that is not correctable and felt to be a contraindication to proceeding with biopsy or lithotripsy per the treating endoscopist; 5. Active suppurative cholangitis with evidence of purulent drainage at the time of papilla visualization; 6. Patients who are not candidates for anesthesia to permit ERCP.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Interventional Group
  • Device: Dragonfly™ 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.

Recruiting Locations

Universtiy of Colorado Hospital
Aurora 5412347, Colorado 5417618 80045
Contact:
Inga Cuba Research Manager
303-724-8892
INGEBORG.CUBA@CUANSCHUTZ.EDU

More Details

NCT ID
NCT07120295
Status
Recruiting
Sponsor
University of Colorado, Denver

Study Contact

Rodolfo Hernandez
303-724-1870
Rodolfo.Hernandez@cuanschutz.edu

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center