Bile Duct AdenocarcinomaPhase 4NCT07120295
Study of Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories
A Phase 4 study testing Dragonfly™ Digital Pancreaticobiliary System in people with Bile Duct Adenocarcinoma and Bile Duct Carcinoma, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Bile Duct Adenocarcinoma, Bile Duct Carcinoma
- What is being tested?
- Dragonfly™ Digital Pancreaticobiliary System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2025to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision to sign and date the consent form;
- Adult patients ≥ 21 years old;
- Any patient who is required to undergo endoscopic retrograde cholangiopancreatography (ERCP) procedure with the clinical need to perform cholangioscopy for:
- Indeterminate biliary stricture, or
- Failed biliary stone extraction with conventional techniques.
- Willing and able to follow study procedures and comply with study follow-up.
Who cannot join
- Pregnancy or lactation;
- Surgically or physiologically altered GI anatomy that precludes advancement of the duodenoscope for biliary cannulation;
- Patients on anti-coagulants and anti-platelet medications that cannot be withheld pre-procedure, except for aspirin, 81mg;
- 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;
- Active suppurative cholangitis with evidence of purulent drainage at the time of papilla visualization;
- Patients who are not candidates for anesthesia to permit ERCP.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Universtiy of Colorado Hospital
Aurora, Colorado, 80045
Inga Cuba Research Manager, 303-724-8892, INGEBORG.CUBA@CUANSCHUTZ.EDU
Sandra Boimbo DART Program Director, 303-724-8892, SANDRA.BOIMBO@CUANSCHUTZ.EDU
About this study
Official title: Prospective Multicenter Clinical Performance Study of a Single-use Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories
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.
- Conditions
- Bile Duct Adenocarcinoma, Bile Duct Carcinoma
- Being tested
- Dragonfly™ Digital Pancreaticobiliary System
- Medical subject headings
- Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dragonfly™ Digital Pancreaticobiliary SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Not described Receives: Device: Dragonfly™ Digital Pancreaticobiliary System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 6 months
Secondary outcomes (13)
Total procedure time
Will evaluate the total procedure time for bile duct stones.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Ergonomics
Will evaluate ergonomics by collecting anthropometric data from physician users. Will provide product performance evaluation data.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Usability
Will assess usability by the System Usability Scale. Will provide product performance evaluation data.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
User satisfaction
Will assess user satisfaction with the Net Promoter Score. Will provide product performance evaluation data.
Measured: 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.
Measured: Up to 6 months
Work
Will assess the subjective assessment of work by the National Aeronautics and Space Administration-Task
Measured: 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.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start11 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Dragonfly Endoscopy Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120295
- Sponsor's protocol ID
- 23-2548.cc
- Other IDs
- DGFLY-CLIN-2023-01
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Clinical Performance Study of a Single-use Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories
- ClinicalTrials.gov ID
- NCT07120295
- Acronym / sponsor ID
- 23-2548.cc
- Conditions
- Bile Duct Adenocarcinoma, Bile Duct Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Dragonfly Endoscopy Inc
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Device: Dragonfly™ Digital Pancreaticobiliary System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision to sign and date the consent form;
- Adult patients ≥ 21 years old;
- Any patient who is required to undergo endoscopic retrograde cholangiopancreatography (ERCP) procedure with the clinical need to perform cholangioscopy for:
- Willing and able to follow study procedures and comply with study follow-up.
Key exclusion criteria (6 listed)
- Pregnancy or lactation;
- Surgically or physiologically altered GI anatomy that precludes advancement of the duodenoscope for biliary cannulation;
- Patients on anti-coagulants and anti-platelet medications that cannot be withheld pre-procedure, except for aspirin, 81mg;
- 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;
- Active suppurative cholangitis with evidence of purulent drainage at the time of papilla visualization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dragonfly™ Digital Pancreaticobiliary SystemDragonfly™ 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. | Device | Interventional Group |
Primary outcome
Stone Fragmentation- Clearing of Biliary Stones
Time frame: Up to 6 months
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.
Tissue Acquisition during endoscopy procedure
Time frame: Up to 6 months
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.
13 secondary outcomes
Total procedure time
Time frame: Up to 6 months
Product performance evaluation as rated by the endoscopist operating the DPS System
Time frame: Up to 6 months
DPS Functionality during Endoscopy Procedures
Time frame: Up to 6 months
Ergonomics
Time frame: Up to 6 months
Lithotripsy fragmentation time
Time frame: Up to 6 months
Product Performance
Time frame: Up to 6 months
Usability
Time frame: At the completion of the study
Visualization of biliary strictures
Time frame: Up to 6 months
Visualization of stone or stricture characteristics
Time frame: Up to 6 months
User satisfaction
Time frame: At the completion of the study
Passing of device to target area
Time frame: Up to 6 months
Work
Time frame: After each case
Bile duct stone recurrence rate
Time frame: At 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dragonfly™ Digital Pancreaticobiliary System in people with Bile Duct Adenocarcinoma and Bile Duct Carcinoma, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodolfo Hernandez (303-724-1870, Rodolfo.Hernandez@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone Fragmentation- Clearing of Biliary Stones (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.