Dragonfly™ Scope for Bile Duct Cancer

Overseen By Rodolfo Hernandez

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Colorado, Denver

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Pregnancy, Altered GI anatomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Dragonfly™ Digital Pancreaticobiliary System to determine its effectiveness in treating certain bile duct issues. The researchers aim to assess whether the device can successfully break down tough bile duct stones and collect tissue samples during a routine endoscopy, a procedure used to examine the digestive tract. This trial targets individuals requiring an endoscopy due to difficult-to-remove bile duct stones or unclear bile duct narrowing. Participants must be prepared to follow all study steps and attend follow-up visits. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Will I have to stop taking my current medications?

If you are taking anti-coagulants or anti-platelet medications, you may need to stop them before the procedure, except for low-dose aspirin (81mg). The trial does not specify other medication restrictions.

What is the safety track record for the Dragonfly™ Digital Pancreaticobiliary System?

Research has shown that the Dragonfly™ Digital Pancreaticobiliary System aids doctors in viewing the bile and pancreatic ducts, assisting in the diagnosis and treatment of certain conditions. Earlier studies found that most patients with bile duct and liver cancers did not experience serious side effects when using the system. Already approved for other procedures, it is generally considered safe for patients. However, discussing any concerns with a doctor is always advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Dragonfly™ Digital Pancreaticobiliary System is unique because it offers a new way to visualize and treat bile duct cancer using advanced digital imaging. Unlike traditional methods that rely on more invasive techniques, this system uses a digital scope to provide high-resolution images, potentially allowing for more precise targeting of cancerous tissues. Researchers are excited about this treatment because it could lead to more accurate diagnoses and effective treatments with less discomfort for patients. Additionally, the potential for real-time imaging means quicker adjustments during procedures, which could improve outcomes.

What evidence suggests that the Dragonfly™ Scope is effective for bile duct cancer?

Research has shown that the Dragonfly™ Digital Pancreaticobiliary System, which trial participants will receive, effectively treats bile duct issues. This device allows doctors to see inside the bile and pancreatic ducts. It breaks up hard bile duct stones and collects tissue samples during procedures. Studies indicate it offers improved visualization and guidance during these procedures. Already approved for use, this system has successfully managed bile duct stones, suggesting it will work well for similar conditions. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This clinical trial is for up to 75 people with biliary disorders, such as bile duct stones or intermediate biliary strictures. Participants will be involved in a study assessing the performance of a new endoscopic tool during their scheduled procedure.

Inclusion Criteria

Provision to sign and date the consent form

I am willing and able to follow the study's procedures and attend all follow-up visits.

I am 21 years old or older.

Exclusion Criteria

I cannot undergo anesthesia for an ERCP procedure.

I am taking blood thinners that can't be stopped, except for low-dose aspirin.

I cannot have a specific GI procedure due to my altered GI anatomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopy procedures using the Dragonfly™ Pancreaticobiliary Scope to achieve stone fragmentation and tissue specimen collection

Up to 6 months

Multiple visits as required for procedures

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of stone recurrence and usability

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Dragonfly™ Digital Pancreaticobiliary System

Trial Overview The Dragonfly™ Digital Pancreaticobiliary System is being tested for its effectiveness in fragmenting difficult biliary stones and collecting tissue samples. The trial will evaluate the device's functionality, performance as rated by the endoscopist, and overall usability.

How Is the Trial Designed?

Group I: Interventional Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Dragonfly Endoscopy Inc

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07120295

Study of Large Channel Digital Pancreaticobiliary Scope ... Dragonfly™ Digital Pancreaticobiliary System is indicated for use in the direct visualization of the biliary and pancreatic ducts for diagnostic ...

2. patlynk.com patlynk.com/trial/NCT07120295

Digital Pancreaticobiliary Scope for Biliary Disorders This study focuses on evaluating a new tool called the Dragonfly™ Pancreaticobiliary Scope, designed for people with bile duct problems like stones or ...

3. withpower.com withpower.com/trial/phase-4-cholangiocarcinoma-7-2025-919ea

Dragonfly™ Scope for Bile Duct Cancer Trial Overview The Dragonfly™ Digital Pancreaticobiliary System is being tested for its effectiveness in fragmenting difficult biliary stones and collecting ...

4. medtronic.com medtronic.com/en-us/healthcare-professionals/products/digestive-gastrointestinal/ercp-devices/dragonfly-pancreaticobiliary-system.html

Dragonfly™* Pancreaticobiliary System Dragonfly™* enables direct visualization and device guidance for diagnostic and therapeutic endoscopic procedures in thepancreaticobiliary system.

5. trialstoday.org trialstoday.org/trial/NCT07120295

Study of Large Channel Digital Pancreaticobiliary Scope ... This study plans to enroll up to 75 research subject who have a biliary disorder such as bile duct stones or intermediate biliary strictures.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K233752.pdf

May 2, 2024 CenterPoint Systems LLC Conner Johnson ... The Dragonfly Pancreaticobiliary Scope is a sterile, single-use endoscope used for single- operator per-oral 2holoangiopancreatoscopy. The ...

7. giejournal.org giejournal.org/article/S0016-5107(24)03189-4/fulltext

Pancreas and biliary ablation devices This report focuses on devices and techniques and the emerging indications to perform chemical, radiation-based, and electrosurgical ablations in the ...