Recruiting

Digital Pancreaticobiliary Scope for Biliary Disorders

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What is being tested

Dragonfly™ Digital Pancreaticobiliary System

Device
Who is being recruted

Bile Duct Adenocarcinoma

+ Bile Duct Carcinoma
Over 21 Years
+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: August 2025

See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Study ContactRodolfo Hernandez
Last updated: September 5, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 11, 2025Actual date on which the first participant was enrolled.

This study focuses on evaluating a new tool called the Dragonfly™ Pancreaticobiliary Scope, designed for people with bile duct problems like stones or strictures. Up to 75 participants with these conditions will be part of the research. The goal is to see if this scope works well in breaking down tough bile duct stones and in gathering tissue samples for analysis. The study aims to improve the effectiveness of endoscopy procedures for these issues, potentially leading to better patient outcomes and less invasive treatments. Participants undergoing a scheduled endoscopy will use the Dragonfly™ Scope along with its accessories to treat their bile duct condition. The scope's ability to fragment stones and collect tissue samples will be closely monitored. Endoscopists will also evaluate the product's performance, focusing on how easy it is to use and how well it functions during procedures. This feedback is crucial in determining the scope's effectiveness and in making any necessary adjustments for future use.

Official TitleProspective Multicenter Clinical Performance Study of a Single-use Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories 
Principal SponsorUniversity of Colorado, Denver
Study ContactRodolfo Hernandez
Last updated: September 5, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
75 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 21 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bile Duct Adenocarcinoma
Bile Duct Carcinoma
Criteria
6 inclusion criteria required to participate
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

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6 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Study Objectives
Primary Objectives

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.

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.
Secondary Objectives

Will evaluate the total procedure time for bile duct stones.

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.

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.

Will evaluate ergonomics by collecting anthropometric data from physician users. Will provide product performance evaluation data.

Will evaluate lithotripsy fragmentation time for bile duct stones. Will summarize with descriptive statistics and report success rates.

Will evaluate product performance for indeterminate biliary strictures as rated by the endoscopist operating the DPS system. Will summarize with descriptive statistics and report success rates.

Will assess usability by the System Usability Scale. Will provide product performance evaluation data.

Will evaluate the ability to adequately visualize biliary strictures, including the presence of both neoplastic (irregular nodular mucosa, irregular papillary projections, intraductal or villous mass, dilated and tortuous vessels with branching, infiltrative stricture, ulceration, and contact friability/ease of oozing) and benign (concentric, bandlike scar, uniform projections, thin vessels) characteristics. Will summarize with descriptive statistics and report success rates.

Will evaluate usability by the ability to visualize stone or stricture characteristics as rated by the endoscopist operating the DPS system.

Will assess user satisfaction with the Net Promoter Score. Will provide product performance evaluation data.

Will evaluate usability by the ability to pass the lithotripsy device and/or stone removal device to the target area as rated by the endoscopist operating the DPS system.

Will assess the subjective assessment of work by the National Aeronautics and Space Administration-Task

Will evaluate the bile duct stone recurrence rate. Will summarize with descriptive statistics and report success rates.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Universtiy of Colorado HospitalAurora, United StatesSee the location
Recruiting
One Study Center