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

NCT07120295 | Recruiting Phase 4 DMC FDA Device

• 2 other identifiers: 23-2548.ccDGFLY-CLIN-2023-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bile Duct Adenocarcinoma; Bile Duct Carcinoma

Outcome Measures

Primary Outcomes (2)

• Stone Fragmentation- Clearing of Biliary Stones

  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.

  Up to 6 months

• Tissue Acquisition during endoscopy procedure

  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.

  Up to 6 months

Secondary Outcomes (13)

• Total procedure time

  Up to 6 months

• Product performance evaluation as rated by the endoscopist operating the DPS System

  Up to 6 months

• DPS Functionality during Endoscopy Procedures

  Up to 6 months

• Ergonomics

  Up to 6 months

• Lithotripsy fragmentation time

  Up to 6 months

Study Arms (1)

Interventional Group

EXPERIMENTAL

Device: Dragonfly™ Digital Pancreaticobiliary System

Interventions

Dragonfly™ Digital Pancreaticobiliary System DEVICE

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.

Interventional Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy or lactation;
• Surgically or physiologically altered GI anatomy that precludes advancement of the duodenoscope for biliary cannulation;
• Patients on anti-coagulants and anti-platelet medications that cannot be withheld pre-procedure, except for aspirin, 81mg;
• 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;
• Active suppurative cholangitis with evidence of purulent drainage at the time of papilla visualization;
• Patients who are not candidates for anesthesia to permit ERCP.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Dragonfly Endoscopy Inc: collaborator

Study Sites (1)

Universtiy of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Rodolfo Hernandez

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: August 13, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

US (1)