NCT07120295 Study of Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories
| NCT ID | NCT07120295 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Colorado, Denver |
| Condition | Bile Duct Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-08-11 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 75 participants in total. It began in 2025-08-11 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07120295 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Bile Duct Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07120295 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07120295 currently recruiting?
Yes, NCT07120295 is actively recruiting participants. Contact the research team at Rodolfo.Hernandez@cuanschutz.edu for enrollment information.
Where is the NCT07120295 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT07120295 clinical trial?
NCT07120295 is sponsored by University of Colorado, Denver. The trial plans to enroll 75 participants.