Digital Pancreaticobiliary Scope for Biliary Disorders
Dragonfly™ Digital Pancreaticobiliary System
Adenocarcinoma+3
+ Carcinoma
+ Neoplasms
Treatment Study
Summary
Study start date: August 11, 2025
Actual 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.75 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
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