Large-channel digital pancreaticobiliary scope with compatible accessories

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Universtiy of Colorado Hospital
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Rodolfo Hernandez
• Email: Rodolfo.Hernandez@cuanschutz.edu
• Phone: 303-724-1870

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Anti-blood-vessel therapy after immunotherapy for advanced bile duct or gallbladder cancer.

  This study will test whether giving the anti-angiogenic drug anlotinib after first-line immunotherapy helps people with advanced bile duct or gallbladder cancer live longer without their disease getting worse.

  Recruiting Phase 2 First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT07025174

• Imaging method for digestive system cancer using targeted PET scans

  This study is testing a new type of PET scan to see if it can better help doctors find and diagnose cancers in the digestive system.

  Recruiting RenJi Hospital · Shanghai, Shanghai Municipality · NCT06715839

• Orientation Intervention to Rapid Response Teams (ORIENT-RRT) for New Graduate Nurses

  The study tests a 12-hour orientation program with a rapid response nurse to see if it improves knowledge, confidence, and nursing practices for new graduate nurses on acute care units.

  Recruiting University of Colorado, Denver · Aurora, Colorado · NCT07897851

• Supplemental Mobility for older adults in skilled nursing facilities

  This pilot tests whether adding a mobility aide to support walking and transfers alongside regular rehab helps older adults in SNFs after hospitalization see more daily activity and safer mobility.

  Recruiting University of Colorado, Denver · Aurora, Colorado and 1 other locations · NCT07872384

• AI check for retained objects on intraoperative X-rays

  A real-world test to see if an AI system can detect retained surgical items on intraoperative X-rays without changing patient care.

  Recruiting University of Colorado, Denver · Aurora, Colorado · NCT07858162

• Cyclic vs. Constant Estradiol for Brain Health in Menopause

  This study tests whether cyclic or continuous estradiol patches improve brain health and wellbeing in healthy postmenopausal adults.

  Recruiting Phase 4 University of Colorado, Denver · Aurora, Colorado · NCT07831499

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.