RECRUITING

Study of Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Multicenter Clinical Performance Study of a Single-use Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories

Quick Facts

Study Start:2025-08-11
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07120295

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision to sign and date the consent form;
  2. 2. Adult patients ≥ 21 years old;
  3. 3. Any patient who is required to undergo endoscopic retrograde cholangiopancreatography (ERCP) procedure with the clinical need to perform cholangioscopy for:
  4. 1. Indeterminate biliary stricture, or
  5. 2. Failed biliary stone extraction with conventional techniques.
  6. 4. Willing and able to follow study procedures and comply with study follow-up.
  1. 1. Pregnancy or lactation;
  2. 2. Surgically or physiologically altered GI anatomy that precludes advancement of the duodenoscope for biliary cannulation;
  3. 3. Patients on anti-coagulants and anti-platelet medications that cannot be withheld pre-procedure, except for aspirin, 81mg;
  4. 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. 5. Active suppurative cholangitis with evidence of purulent drainage at the time of papilla visualization;
  6. 6. Patients who are not candidates for anesthesia to permit ERCP.

Contacts and Locations

Study Contact

Rodolfo Hernandez
CONTACT
303-724-1870
Rodolfo.Hernandez@cuanschutz.edu

Study Locations (Sites)

Universtiy of Colorado Hospital
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-11
Study Completion Date2028-12

Study Record Updates

Study Start Date2025-08-11
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Bile Duct Adenocarcinoma
  • Bile Duct Carcinoma