Study of Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision to sign and date the consent form;
Adult patients ≥ 21 years old;
Indeterminate biliary stricture, or
Failed biliary stone extraction with conventional techniques.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Dragonfly™ Digital Pancreaticobiliary System
DeviceDragonfly™ 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.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Interventional GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 6 months2
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.
Time frame
Up to 6 monthsSecondary outcomes
1
Total procedure time
Will evaluate the total procedure time for bile duct stones.
Time frame
Up to 6 months2
Product performance evaluation as rated by the endoscopist operating the DPS System
Will evaluate the number of procedures required to achieve bile duct stone clearance after referral. Will summarize with descriptive statistics and report success rates. Ninety-five percent confidence intervals will be provided for descriptive statistics.
Time frame
Up to 6 months3
DPS Functionality during Endoscopy Procedures
Will assess whether the DPS functioned as intended in combination with the commercially available accessories. Functioned as intended is defined as the ability to set up, provide visualization, deliver the accessory to the target location, use of the accessory according to the instructions for use. Will summarize with descriptive statistics and report success rates.
Time frame
Up to 6 months4
Ergonomics
Will evaluate ergonomics by collecting anthropometric data from physician users. Will provide product performance evaluation data.
Time frame
Up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
Dragonfly Endoscopy Inc
Collaborator
Source ClinicalTrials.gov