Large-channel digital pancreaticobiliary scope with compatible accessories
Prospective Multicenter Clinical Performance Study of a Single-use Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories
This study will test whether the Dragonfly large-channel digital pancreaticobiliary scope and its accessories can fragment difficult bile duct stones and obtain tissue samples during ERCP in adults with biliary disorders.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT07120295 on ClinicalTrials.gov |
What this trial studies
Up to 75 adults scheduled for ERCP who need cholangioscopy for indeterminate biliary strictures or for failed biliary stone extraction will be enrolled. The Dragonfly Digital Pancreaticobiliary System will be used with commercially available accessories during the participant's planned procedure. Key outcomes include successful fragmentation of difficult biliary stones, adequacy of tissue specimens obtained, and product performance as rated by the operating endoscopist, along with ergonomics and usability assessments. Data will be collected during the procedure and at scheduled follow-up to capture device performance and any procedure-related complications.
Who should consider this trial
Good fit: Adults aged 21 or older who are scheduled for ERCP and require cholangioscopy for an indeterminate biliary stricture or after failed biliary stone extraction, who can consent and comply with follow-up, are ideal candidates.
Not a fit: Patients who are pregnant or lactating, have altered GI anatomy that prevents duodenoscope access, have uncorrectable coagulopathy or thrombocytopenia, cannot safely stop certain anticoagulants, or have active suppurative cholangitis are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the device could make it easier to break difficult bile duct stones and obtain diagnostic tissue during ERCP, potentially reducing the need for additional procedures.
How similar studies have performed: Other digital cholangioscopy systems have shown utility for stone fragmentation and tissue acquisition, but this large-channel Dragonfly configuration is a newer device being tested for compatibility and performance.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aurora, Colorado
- Universtiy of Colorado Hospital — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Rodolfo Hernandez
- Email: Rodolfo.Hernandez@cuanschutz.edu
- Phone: 303-724-1870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.