A Phase 4 interventional study of Dragonfly™ Digital Pancreaticobiliary System in Bile Duct Adenocarcinoma and Bile Duct Carcinoma, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of Colorado, Denver · Phase 4, Interventional, and Treatment
Among 145 studies in Bile Duct Neoplasms with a site in United States — 15 open to participants now, 24 under way, 1 of them phase 3. Bile Duct Neoplasms · United States.
Among the 145 studies in Bile Duct Neoplasms with a site in United States, this one is the 27th largest by planned enrollment of the 115 interventional ones that give a count, is one of 2 that started in 2025, is the only one in phase 4, reaches primary completion later than 12 of the 23 other live ones, and was the 142nd registered.
254 studies on the registry are indexed under Bile Duct Neoplasms; 44 are open to participants now.
Browse Bile Duct Neoplasms studies →15 of the 145 studies in Bile Duct Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Full-Life Technologies UK Limited · Sites in United States, Australia
Ages 18+
Orlando Health, Inc. · Sites in United States
Ages 18–100
BioNTech SE · Sites in United States, Australia, Germany and 2 more countries
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
Beth Israel Deaconess Medical Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 36 Bile Duct Neoplasms studies recruiting now, 21 (58%) set no upper age limit and 6 (17%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
145 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 55 · Phase 2 69 · Phase 3 11 · Phase 4 1
First in 1994; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 75 is above the median of 53 across 190 interventional studies indexed under Bile Duct Neoplasms.
Median enrollment 43 across the 115 interventional studies, 184 across the 18 observational. Of the 108 that completed or were terminated, 42 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
36 of 145 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 1 study filed under Bile Duct Neoplasms — fewer than ten, so there is no comparison to draw.
6 of the studies in Bile Duct Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06048133Nataliya UbohaStudy of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC) | 2026-12 |
| NCT00582647Memorial Sloan Kettering Cancer CenterCollection of Tissue & Blood From Patients w/ Benign & Malignant Tumors of the Soft Tissue & Gastrointestinal Tract | 2026-12 |
| NCT05000294University of FloridaAtezolizumab Plus Tivozanib in Immunologically Cold Tumor Types | 2026-12 |
| NCT05655949Beth Israel Deaconess Medical CenterY-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio | 2026-12-01 |
| NCT04907643Cedars-Sinai Medical CenterVirtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes | 2027-03-31 |
Add all 6 to your calendar (.ics) → With an account.
Among the 145 studies in Bile Duct Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Any patient who is required to undergo endoscopic retrograde cholangiopancreatography (ERCP) procedure with the clinical need to perform cholangioscopy for:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Dragonfly™ Digital Pancreaticobiliary System
Dragonfly™ Digital Pancreaticobiliary System is indicated for use in the direct visualization of the biliary and pancreatic ducts for diagnostic and therapeutic interventions during endoscopic procedures. DPS is a single-use device that serves as an access and delivery catheter used with a proprietary DDC. The DDC is intended to control auto-illumination, and process images from the DPS for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.
Stone Fragmentation- Clearing of Biliary Stones
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.
Time frame: Up to 6 months
Tissue Acquisition during endoscopy procedure
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.
Time frame: Up to 6 months
Total procedure time
Will evaluate the total procedure time for bile duct stones.
Time frame: Up to 6 months
Product performance evaluation as rated by the endoscopist operating the DPS System
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.
Time frame: Up to 6 months
DPS Functionality during Endoscopy Procedures
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.
Time frame: Up to 6 months
Ergonomics
Will evaluate ergonomics by collecting anthropometric data from physician users. Will provide product performance evaluation data.
Time frame: Up to 6 months
Lithotripsy fragmentation time
Will evaluate lithotripsy fragmentation time for bile duct stones. Will summarize with descriptive statistics and report success rates.
Time frame: Up to 6 months
Product Performance
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.
Time frame: Up to 6 months
Usability
Will assess usability by the System Usability Scale. Will provide product performance evaluation data.
Time frame: At the completion of the study
Visualization of biliary strictures
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.
Time frame: Up to 6 months
Visualization of stone or stricture characteristics
Will evaluate usability by the ability to visualize stone or stricture characteristics as rated by the endoscopist operating the DPS system.
Time frame: Up to 6 months
User satisfaction
Will assess user satisfaction with the Net Promoter Score. Will provide product performance evaluation data.
Time frame: At the completion of the study
Passing of device to target area
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.
Time frame: Up to 6 months
Work
Will assess the subjective assessment of work by the National Aeronautics and Space Administration-Task
Time frame: After each case
Bile duct stone recurrence rate
Will evaluate the bile duct stone recurrence rate. Will summarize with descriptive statistics and report success rates.
Time frame: At 6 months
Started Aug 2025 (actual). Primary completion is estimated for Dec 2027, 28 months after the start.
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