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Recruiting NCT07120295

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

Phase IV Interventional Bile Duct Adenocarcinoma Bile Duct Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dragonfly™ Digital Pancreaticobiliary System.
Who it may be relevant to
Registry conditions: Bile Duct Adenocarcinoma, Bile Duct Carcinoma. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 incl

Primary outcome measures

  • Stone Fragmentation- Clearing of Biliary Stones [Time frame: Up to 6 months]
  • Tissue Acquisition during endoscopy procedure [Time frame: Up to 6 months]
Secondary outcome measures (12)
  • Total procedure time [Time frame: Up to 6 months]
  • Product performance evaluation as rated by the endoscopist operating the DPS System [Time frame: Up to 6 months]
  • DPS Functionality during Endoscopy Procedures [Time frame: Up to 6 months]
  • Ergonomics [Time frame: Up to 6 months]
  • Lithotripsy fragmentation time [Time frame: Up to 6 months]
  • Product Performance [Time frame: Up to 6 months]
  • Usability [Time frame: At the completion of the study]
  • Visualization of biliary strictures [Time frame: Up to 6 months]
  • Visualization of stone or stricture characteristics [Time frame: Up to 6 months]
  • User satisfaction [Time frame: At the completion of the study]
  • Passing of device to target area [Time frame: Up to 6 months]
  • Work [Time frame: After each case]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Universtiy of Colorado Hospital — Aurora

Identifiers

NCT: NCT07120295 · 23-2548.cc · DGFLY-CLIN-2023-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗